Spiration Valve System
Gyrus ACMI, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1037007 | 1037007 | GYRUS ACMI, INC. | 1 | N | 2026-01-01 | 2925 Appling Rd BARTLETT TN US 38133 |
| 3003790304 | 3003790304 | GYRUS ACMI, INC. | 1 | N | 2026-01-01 | 800 West Park Drive Westborough MA US 01581 |
| 3004450998 | 3004450998 | Gyrus ACMI, Inc. | 1 | N | 2026-01-01 | 6675 185th Avenue NE Redmond WA US 98052 |
| 3011050570 | 3011050570 | Gyrus ACMI, Inc. | 1 | N | 2026-01-01 | 9600 Louisiana Ave North Brooklyn Park MN US 55445 |
| 1519132 | 1519132 | GYRUS ACMI, INC. | 1 | N | 2020-04-25 | 93 NORTH PLEASANT ST. Norwalk OH US 44857 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 173201 | 1773606456 | P870076 | FALOPE RING BAND AND APPLICATOR SYSTEMS | KNH | 1993-09-29 |
| 120382 | 1477766133 | P180007 | Spiration® Valve System | NJK | 2018-12-03 |
| 85098 | 1477766133 | P180007 | Spiration® Valve System | NJK | 2018-12-03 |
| 173201 | 1957900258 | K994418 | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | HIH | 2000-01-24 |
| 173201 | 1285971246 | K993041 | OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT | FAJ | 2000-03-30 |
| 85015 | 1755527353 | K992994 | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; | ERL | 1999-11-23 |
| 173201 | 1755527353 | K992994 | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; | ERL | 1999-11-23 |
| 85098 | 1755527353 | K992994 | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; | ERL | 1999-11-23 |
| 173201 | 1988984750 | K992901 | GYNECARE VERSAPOINT G-VAP ELECTRODE | HIH | 2000-01-18 |
| 85015 | 1728227679 | K992222 | FLUOROPLASTIC VENTILATION TUBES | ETD | 1999-08-26 |
| 85015 | 2035633332 | K992222 | FLUOROPLASTIC VENTILATION TUBES | ETD | 1999-08-26 |
| 85033 | 2035633332 | K992222 | FLUOROPLASTIC VENTILATION TUBES | ETD | 1999-08-26 |
| 85098 | 2035633332 | K992222 | FLUOROPLASTIC VENTILATION TUBES | ETD | 1999-08-26 |
| 173201 | 2035633332 | K992222 | FLUOROPLASTIC VENTILATION TUBES | ETD | 1999-08-26 |
| 85098 | 1240002712 | K992126 | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | GCX | 1999-08-03 |
| 173201 | 1052141989 | K990628 | GYRUS ENDOUROLOGY SYSTEM | KNS | 1999-06-29 |
| 85098 | 1052141989 | K990628 | GYRUS ENDOUROLOGY SYSTEM | KNS | 1999-06-29 |
| 85015 | 1500763314 | K990601 | BOJRAB MICRO-TORP, MODEL 7014-5845 | ETA | 1999-03-31 |
| 173201 | 1802125887 | K984255 | OLYMPUS HX-20 SERIES LIGATING DEVICE | MND | 1999-01-12 |
| 85015 | 1513276957 | K983276 | HYDROFERA BACTERISTATIC NASAL DRESSING | EMX | 1999-09-14 |
| 173201 | 1513276957 | K983276 | HYDROFERA BACTERISTATIC NASAL DRESSING | EMX | 1999-09-14 |
| 173201 | 1144881466 | K982738 | VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) | HIH | 1999-03-01 |
| 173201 | 1496990229 | K982734 | OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE | ODG | 1998-10-05 |
| 173201 | 1914812568 | K982733 | OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE | ITX | 1998-10-28 |
| 85015 | 1909523625 | K982717 | SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 | GEI | 1998-11-02 |
| 173201 | 1909523625 | K982717 | SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 | GEI | 1998-11-02 |
| 85098 | 1909523625 | K982717 | SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200 | GEI | 1998-11-02 |
| 173201 | 1059774671 | K982289 | HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## | KNS | 1998-08-19 |
| 173201 | 1067586029 | K981993 | OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA | ODA | 1998-08-21 |
| 85033 | 1891387699 | K980972 | RIGID CULDOSCOPE AND ACCESSORIES | HEW | 1998-06-12 |
| 85098 | 1891387699 | K980972 | RIGID CULDOSCOPE AND ACCESSORIES | HEW | 1998-06-12 |
| 173201 | 1891387699 | K980972 | RIGID CULDOSCOPE AND ACCESSORIES | HEW | 1998-06-12 |
| 85033 | 1462218893 | K980492 | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) | FFK | 1998-11-17 |
| 173201 | 1462218893 | K980492 | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) | FFK | 1998-11-17 |
| 85098 | 1462218893 | K980492 | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) | FFK | 1998-11-17 |
| 173201 | 1671352102 | K980366 | AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240 | GEI | 1998-02-27 |
| 85015 | 1225139473 | K974311 | VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT | KHJ | 1998-03-04 |
| 173201 | 1225139473 | K974311 | VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT | KHJ | 1998-03-04 |
| 85098 | 1225139473 | K974311 | VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT | KHJ | 1998-03-04 |
| 85015 | 1978641833 | K974232 | ESSENTIAL SHAVER SYSTEM | EQJ | 1998-01-12 |
| 85098 | 1494255120 | K973820 | USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE | FAS | 1998-05-12 |
| 173201 | 1494255120 | K973820 | USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE | FAS | 1998-05-12 |
| 85015 | 1979819349 | K973701 | SOMNUS TISSUE COAGULATING ELECTRODE | GEI | 1998-01-30 |
| 173201 | 1979819349 | K973701 | SOMNUS TISSUE COAGULATING ELECTRODE | GEI | 1998-01-30 |
| 85098 | 1979819349 | K973701 | SOMNUS TISSUE COAGULATING ELECTRODE | GEI | 1998-01-30 |
| 85015 | 1823347142 | K973618 | SOMNOPLASTY SYSTEM | GEI | 1997-12-19 |
| 173201 | 1823347142 | K973618 | SOMNOPLASTY SYSTEM | GEI | 1997-12-19 |
| 85098 | 1823347142 | K973618 | SOMNOPLASTY SYSTEM | GEI | 1997-12-19 |
| 85015 | 1193999555 | K973286 | ENT IRRIGATING PUMP (70327700) | ERL | 1997-09-29 |
| 85015 | 1283824519 | K973286 | ENT IRRIGATING PUMP (70327700) | ERL | 1997-09-29 |
| 173201 | 1799678910 | K971881 | COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS | FJL | 1997-08-12 |
| 85015 | 1898166342 | K971450 | SOMNOPLASTY SYSTEM | GEI | 1997-07-17 |
| 173201 | 1898166342 | K971450 | SOMNOPLASTY SYSTEM | GEI | 1997-07-17 |
| 85098 | 1898166342 | K971450 | SOMNOPLASTY SYSTEM | GEI | 1997-07-17 |
| 173201 | 1401757430 | K971166 | OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE | EWY | 1997-08-27 |
| 85015 | 1292472064 | K970809 | BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL | GEI | 1997-06-18 |
| 173201 | 1292472064 | K970809 | BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL | GEI | 1997-06-18 |
| 85098 | 1292472064 | K970809 | BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL | GEI | 1997-06-18 |
| 85015 | 1781680477 | K964334 | EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) | GCJ | 1996-12-09 |
| 173201 | 1036958696 | K963184 | OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM | GCJ | 1996-12-31 |
| 173201 | 2020378066 | K963033 | BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES | EOQ | 1996-09-09 |
| 85015 | 1499294905 | K962564 | RICHARDS TOTAL/PARTIAL PROSTHESIS | ETB | 1997-01-22 |
| 85015 | 1792049960 | K962564 | RICHARDS TOTAL/PARTIAL PROSTHESIS | ETB | 1997-01-22 |
| 173201 | 1604646543 | K962555 | OLYMPUS FB SERIES BIOPSY FORCEPS | EOQ | 1996-07-30 |
| 173201 | 1034547630 | K962533 | OLYPUS FG SERIES GRASPING FORCEPS | EOQ | 1996-08-09 |
| 173201 | 1246031844 | K962485 | OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) | EOQ | 1996-08-20 |
| 173201 | 1467102918 | K962482 | SCUBA SYSTEM | HIH | 1996-11-01 |
| 85015 | 1725287163 | K960477 | VENTILATION TUBES | ETD | 1996-02-26 |
| 173201 | 1725287163 | K960477 | VENTILATION TUBES | ETD | 1996-02-26 |
| 85098 | 1725287163 | K960477 | VENTILATION TUBES | ETD | 1996-02-26 |
| 85098 | 1514778182 | K960148 | CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT | FAD | 1996-03-25 |
| 173201 | 1514778182 | K960148 | CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT | FAD | 1996-03-25 |
| 85015 | 1387235042 | K955593 | EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY | EMX | 1995-12-22 |
| 173201 | 1618400520 | K955403 | OES LAPARO-THORACO VIDEOSCOPE TYPE V | HET | 1996-03-11 |
| 173201 | 1143645266 | K955065 | OLYMPUS FB SERIES BIOPSY FORCEPS | FCL | 1996-01-24 |
| 85098 | 1168939218 | K954824 | PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE | KKX | 1996-04-23 |
| 85015 | 1379353051 | K953096 | ESSENTIAL SHAVER SYSTEM | EQJ | 1995-07-28 |
| 173201 | 1379353051 | K953096 | ESSENTIAL SHAVER SYSTEM | EQJ | 1995-07-28 |
| 85015 | 1826815887 | K953096 | ESSENTIAL SHAVER SYSTEM | EQJ | 1995-07-28 |
| 173201 | 1738942144 | K952892 | OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) | ITX | 1996-02-12 |
| 85015 | 1548500840 | K952481 | RICHARDS PORP | ETB | 1995-06-16 |
| 85033 | 1695974454 | K951972 | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS | FBO | 1995-07-21 |
| 85098 | 1695974454 | K951972 | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS | FBO | 1995-07-21 |
| 173201 | 1695974454 | K951972 | CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS | FBO | 1995-07-21 |
| 173201 | 1669732498 | K951445 | OLYMPUS FD-5 HOT BIOPSY FORCEPS | KGE | 1995-05-03 |
| 173201 | 1245740833 | K951354 | OLYMPUS ARTHROSCOPY SYSTEM | HRX | 1995-06-14 |
| 85015 | 1368225400 | K950984 | HAPES MALLEABLE INCUS STAPES | ETB | 1995-03-15 |
| 85015 | 1833934085 | K950984 | HAPES MALLEABLE INCUS STAPES | ETB | 1995-03-15 |
| 85015 | 1914640358 | K950927 | HAPEX MALLEABLE TORP | ETA | 1995-03-21 |
| 85015 | 1041541183 | K950887 | HAPEX INCUS | ETB | 1995-03-15 |
| 85015 | 1576783814 | K950886 | HAPEX PORP | ETB | 1995-03-15 |
| 85015 | 1078789995 | K950885 | HAPEX MALLEABLE PORP | ETB | 1995-03-15 |
| 173201 | 1635909837 | K950455 | DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES | JOS | 1995-05-16 |
| 85015 | 1602516694 | K950024 | EXPANDACELL NASAL PACK WITH AIRWAY | EMX | 1995-02-17 |
| 85098 | 1887842183 | K946296 | QUADRA-COIL URETERAL STENT | FAD | 1995-03-06 |
| 173201 | 1887842183 | K946296 | QUADRA-COIL URETERAL STENT | FAD | 1995-03-06 |
| 173201 | 1587443115 | K945758 | HI-TIP HIGH TEMPERATURE REPLACEMENT TIP | GEI | 1995-04-21 |
| 85098 | 1587443115 | K945758 | HI-TIP HIGH TEMPERATURE REPLACEMENT TIP | GEI | 1995-04-21 |
| 85033 | 1830199273 | K945266 | OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES | GCJ | 1995-02-23 |
| 173201 | 1741129826 | K945262 | OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES | FAJ | 1995-05-26 |
| 173201 | 1053974471 | K944912 | OLYMPUS NBD TUBES | FGE | 1995-06-13 |
| 85033 | 1158805325 | K944025 | SURGICAL INSTRUMENT TRAY | FSM | 1994-11-22 |
| 85098 | 1158805325 | K944025 | SURGICAL INSTRUMENT TRAY | FSM | 1994-11-22 |
| 173201 | 1158805325 | K944025 | SURGICAL INSTRUMENT TRAY | FSM | 1994-11-22 |
| 173201 | 1556216498 | K942986 | ELECTRODES (BLADE, BALL, NEEDLE, AND LOOP) | HGI | 1995-03-21 |
| 173201 | 1064769980 | K942338 | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES | FDT | 1994-11-30 |
| 85098 | 1300088907 | K941952 | SURGITEK INFUSER | FAD | 1994-05-24 |
| 85098 | 1044947072 | K941743 | CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP | HIG | 1995-04-19 |
| 173201 | 1044947072 | K941743 | CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP | HIG | 1995-04-19 |
| 85015 | 1513777859 | K940133 | THE EXPANDACELL EAR PACK | LRD | 1994-05-23 |
| 173201 | 1306126453 | K936304 | ELECTROSURGICAL PENCIL | GEI | 1994-06-13 |
| 85015 | 1776145409 | K936048 | LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) | FST | 1994-03-10 |
| 173201 | 1776145409 | K936048 | LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) | FST | 1994-03-10 |
| 173201 | 1336601073 | K935947 | HI-TOPS ELECTRODES 14-8000 | KNF | 1994-02-28 |
| 85015 | 1442532658 | K935724 | THE EXPANDACELL SINUS PACK | EMX | 1994-05-12 |
| 85015 | 1010337060 | K935235 | ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY | GCM | 1995-03-23 |
| 173201 | 1010337060 | K935235 | ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY | GCM | 1995-03-23 |
| 85098 | 1010337060 | K935235 | ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY | GCM | 1995-03-23 |
| 85015 | 1936197062 | K934432 | OTOVIEW ENDOSCOPY SYSTEM | EWA | 1994-04-25 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEI | 110 | 2026-03-02 |
| ETB | 46 | 2000-10-31 |
| ETD | 29 | 2000-06-19 |
| GCJ | 19 | 2022-03-09 |
| FAD | 19 | 1996-03-25 |
| ERL | 18 | 2022-01-19 |
| FGB | 15 | 2018-03-29 |
| FFK | 15 | 2013-11-26 |
| ETA | 15 | 2000-08-29 |
| HIH | 13 | 2004-03-09 |
| EOQ | 9 | 2021-02-19 |
| EOB | 9 | 2016-01-15 |
| KNS | 9 | 2012-12-14 |
| FEO | 8 | 2017-08-21 |
| FAJ | 7 | 2004-09-10 |
| KTI | 6 | 2020-03-18 |
| FAS | 6 | 2010-02-24 |
| HIG | 6 | 2002-01-08 |
| EMX | 6 | 1999-09-14 |
| KCT | 5 | 2021-09-15 |
| FGE | 5 | 2018-03-08 |
| FDC | 5 | 2002-05-09 |
| FBK | 5 | 2001-08-10 |
| GEX | 4 | 2024-08-23 |
| HHI | 4 | 2017-09-29 |
| HIN | 4 | 2014-11-21 |
| KNY | 4 | 2013-02-04 |
| EYB | 4 | 2005-03-03 |
| ITX | 4 | 2001-05-15 |
| KHJ | 4 | 1998-03-04 |
| EQJ | 4 | 1998-01-12 |
| LYA | 3 | 2018-11-30 |
| FBN | 3 | 2010-03-10 |
| HET | 3 | 2008-09-26 |
| OCU | 3 | 2003-06-03 |
| HAW | 3 | 2003-05-02 |
| KOB | 3 | 2001-09-19 |
| MIX | 3 | 2000-03-01 |
| HEW | 3 | 1998-06-12 |
| FBO | 3 | 1995-07-21 |
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
Gyrus Acmi, Inc.
Gyrus Acmi, Inc.
Gyrus Acmi, Inc.
Gyrus ACMI, Inc.
Gyrus Acmi, Inc.
Gyrus ACMI, Inc.
Gyrus ACMI, Inc.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
GYRUS ACMI, INC.
2024-08-01
2024-08-01
2024-08-01
2024-08-01
2024-08-01
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-25
2024-07-24
2024-07-24
2024-07-24
2024-07-24
2024-07-24
2024-07-24
2024-07-24
2024-07-24
2024-07-24
2024-07-24
2024-07-24
2024-07-24
2024-07-24
2024-07-24