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 |
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| 08682952418144 | DeRoyal | PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI | 2025-05-08 |
| 08682952417437 | DeRoyal | PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI | 2025-05-07 |
| 08682952417451 | DeRoyal | PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI | 2025-05-07 |
| 08682952417482 | DeRoyal | PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI | 2025-05-07 |
| 07612367010924 | Filter, particle, Medela connection | Medela AG | 2024-05-31 |
| 07612367003575 | Change over valve | Medela AG | 2024-05-31 |
| 07612367088169 | Basic | Medela AG | 2024-05-31 |
| 07612367088152 | Basic | Medela AG | 2024-05-31 |
| 07612367088145 | Dominant Flex | Medela AG | 2024-05-31 |
| 07612367088138 | Dominant Flex | Medela AG | 2024-05-31 |
| 07612367011617 | Disposable tube 200cm | Medela AG | 2024-05-31 |
| 08681756017843 | Pergo | PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI | 2023-12-13 |
| 08682952411053 | Pergo | PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI | 2023-12-06 |
| 08682952411121 | Pergo | PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI | 2023-12-06 |
| 10073088159578 | Bemis | Bemis de México, S.A. de C.V. | 2022-08-25 |
| 10073088159530 | Bemis | Bemis de México, S.A. de C.V. | 2022-04-04 |
| 10073088159516 | Bemis | Bemis de México, S.A. de C.V. | 2022-04-04 |
| 10080196034987 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2020-11-26 |
| H78765651910C0 | AngioDynamics | ANGIODYNAMICS, INC. | 2020-03-05 |
| 07613327061659 | AHTO | STRYKER CORPORATION | 2016-09-23 |
| 07613327061499 | AHTO | STRYKER CORPORATION | 2016-09-23 |
| 07613327061475 | AHTO | STRYKER CORPORATION | 2016-09-23 |
| 07613327061406 | StrykeFlow | STRYKER CORPORATION | 2016-09-23 |
| 07613327061369 | StrykeFlow | STRYKER CORPORATION | 2016-09-23 |
| 07613252497165 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613252497158 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613252497141 | Neptune | STRYKER CORPORATION | 2016-09-23 |
| 07613252497134 | Neptune | STRYKER CORPORATION | 2016-09-23 |