Product code GCX
- Device name
- Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6740
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042454 | STRYKER CASSETTE PUMP | Stryker Endoscopy | 2004-12-09 |
| K992126 | CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM | Circon Corp. | 1999-08-03 |
| K972074 | SUCTION INSTRUMENTATION | Walter Lorenz Surgical, Inc. | 1997-07-25 |
| K971022 | CHASE SUCKER | Chase Medical, Inc. | 1997-04-17 |
| K964127 | MEDI-VAC FLEXI-CLEAR SUCTION HANDLE | Allegiance Healthcare Corp. | 1996-12-31 |
| K964519 | CURITY THORACENTESIS TRAY | Kendall Healthcare Products Co. Div.Of Tyco Health | 1996-12-20 |
| K963648 | STRYKER SUCTION REGULATOR | Stryker Endoscopy | 1996-11-26 |
| K962920 | RENTON SUCTION DEVICE U.S. PATENT*4,767,404 | R&S Surgical, LLC | 1996-10-21 |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | Medcare Medical Group, Inc. | 1996-07-19 |
| K960223 | CPR YANKAUER | Custom Pack Reliability | 1996-03-28 |
| K954869 | MEDCARE YANKAUER SUCTION DEVICE | Medcare Custom Packaging, Inc. | 1996-01-19 |
| K954726 | STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) | Stryker Endoscopy | 1995-11-29 |
| K952219 | SUCTION TIP CLEANER CUP | Moore/Gobel | 1995-11-15 |
| K951119 | NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM | American Hydro-Surgical Instruments, Inc. | 1995-06-13 |
| K950464 | SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES | Sscor | 1995-04-25 |
| K931548 | INAMED DEVELOPMENT ASPIRATION TIP | Inamed Development Co. | 1994-01-10 |
| K924570 | OEM MULTI-VAC POWERED SUCTION PUMP | Oem Medical Div. | 1993-08-05 |
| K920912 | THE MEDIC TM | Medical and Environment Designs, Inc. | 1993-07-30 |
| K924337 | PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS | Deknatel, Inc. | 1993-07-28 |
| K924577 | MEDIVAC | Medisonic U.S.A., Inc. | 1993-03-23 |
| K911238 | TAHOE SUCTION IRRIGATOR | Tahoe Pro Instruments | 1992-11-27 |
| K920248 | MODEL SLASE 210 HOLMIUM LASER SYSTEM | Sunrise Technologies, Inc. | 1992-07-21 |
| K914601 | SUCTION CONNECTING TUBING | Bemis Mfg. Co. | 1992-02-07 |
| K912753 | XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL | Xomed-Treace, Inc. | 1991-09-23 |
| K910377 | COOPERSURGICAL MODEL 6080 SMOKE EVACUATOR SYSTEM | CooperSurgical, Inc. | 1991-04-19 |
| K910218 | LAPAROMED CHOLANGIOGRAM VACUUM DEVICE | Laparomed Corp. | 1991-04-08 |
| K905448 | THORA-KLEX CHEST DRAINAGE UNIT | Davol, Inc. | 1991-03-27 |
| K895859 | CONTAIN(TM) | Arbor Technologies, Inc. | 1991-02-07 |
| K896134 | ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. | Goosen Enterprises, Inc. | 1990-08-30 |
| K901937 | CODMAN SUCTION PATTIE | Codman & Shurtleff, Inc. | 1990-07-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840117320987 | Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc Canister | Dynarex Corporation | 2026-09-25 |
| 00848530084011 | Oxygen Accessory | Sunset Healthcare Solutions, Inc. | 2025-06-18 |
| 00848530086435 | Sunset Bulb Tip Yankauer - Non-Vented | Sunset Healthcare Solutions, Inc. | 2018-09-17 |
| 00848530088989 | Portable Suction Machine, Replacement Power Cord (without Adapter) | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530088972 | Portable Suction Machine Replacement Power Adapter (without Cord) | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530088859 | Nasal CPAP Mask — Small | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530086428 | Bulb Tip Yankauer — Vented | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530082475 | Cylinder Wrenches | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530070762 | Cylinder Wrenches for Tank Valve - Without Chain | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530061241 | Washers with Smooth Rubber Ring - Brass | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530061227 | Washers with Rubber Ring - Brass | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530060633 | Washers with Rubber Ring - Aluminum | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530060619 | Washer with Rubber Ring - Brass | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530060572 | Regular Yoke Washer - Brass | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530036034 | ResMed S9 and AirSense 10 Style Hypoallergenic Filters | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530060596 | Oxygen Liter Meter - 0-8 Liter/Minute | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530010690 | 6in HEPA Capsule with Removable Sticker | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530003425 | FILTER,HYDROPHOBIC, SET, BARB | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530003364 | Oxygen Tubing Y-Connector | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530000660 | Christmas Tree Nut and Nipple Adaptor | Sunset Healthcare Solutions, Inc. | 2018-07-29 |
| 00848530060077 | Oxygen In Use Signs | Sunset Healthcare Solutions, Inc. | 2018-07-29 |
| 00848530000707 | Adapter, Pressure Line O2 Treatment | Sunset Healthcare Solutions, Inc. | 2018-07-29 |
| 00848530086596 | CPAP Bedside Holder | Sunset Healthcare Solutions, Inc. | 2018-07-29 |
| 00848530001162 | Washers with Rubber Ring - Brass | Sunset Healthcare Solutions, Inc. | 2018-07-29 |
| 00848530080105 | Comfort Chinstrap | Sunset Healthcare Solutions, Inc. | 2018-05-25 |
| 20885380130950 | MEDI-VAC | Cardinal Health 200, LLC | 2018-03-06 |
| 00848530061357 | Sunset Healthcare Solutions - Bemis - 800cc Suction Canister | Sunset Healthcare Solutions, Inc. | 2016-09-24 |
| 00848530062101 | Sunset Healthcare Solutions 800cc Suction Canister - 1/Case | Sunset Healthcare Solutions, Inc. | 2016-09-23 |
| 00848530061944 | Sunset Healthcare Solutions 800cc Suction Canister - 12/Case | Sunset Healthcare Solutions, Inc. | 2016-09-23 |
| 00848530060411 | Sunset Healthcare Solutions 800cc Suction Canister - 10/Case | Sunset Healthcare Solutions, Inc. | 2016-09-23 |