Product code GCY
- Device name
- Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4680
- Review panel
- SU
- 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 |
|---|---|---|---|
| K972703 | REDYROB-CLOSED WOUND DRAINAGE SYSTEM | B.Braun Medical, Inc. | 1997-10-01 |
| K971036 | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | Interpore Intl. | 1997-06-03 |
| K963839 | CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 | Cordis Corp. | 1996-12-12 |
| K960099 | PENROSE DRAIN MODELS 6001 - 6007 | Sil-Med Corp. | 1996-03-11 |
| K950754 | MACRO SUCTION TUBE MODEL NO 10061 | Dlp, Inc. | 1995-04-25 |
| K936223 | PRESSURE IRRIGATING SYSTEM | Level 1 Technologies, Inc. | 1994-05-12 |
| K930615 | AUTOVAC CLOSED WOUND SUCTION SYSTEM | Boehringer Laboratories | 1994-02-22 |
| K933319 | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM | Birtcher Medical Systems, Inc. | 1993-10-27 |
| K933305 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE | Inman Medical Corp. | 1993-10-05 |
| K933306 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES | Inman Medical Corp. | 1993-10-05 |
| K933170 | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT | Inman Medical Corp. | 1993-09-16 |
| K931950 | POOLE TIP SUCTION PROBE | Mayaguez Medical Center | 1993-08-11 |
| K931856 | 5.0 MM IRRIGATION/ASPIRATION PROBE | Mayaguez Medical Center | 1993-08-10 |
| K925024 | ORC TAPPERED IRRIGATING PROBE | O.R. Concepts, Inc. | 1993-05-21 |
| K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | 1993-05-17 |
| K920819 | ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN | Astra Meditec AB | 1993-03-24 |
| K925989 | KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-02-26 |
| K925749 | KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-02-01 |
| K922895 | J-VAC BULB SUCTION RESERVOIR | Johnson & Johnson Medical, Inc. | 1992-09-15 |
| K915867 | SOLCOVAC WOUND DRAINAGE SYSTEM | Solco Basle, Inc. | 1992-08-14 |
| K915536 | DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC | Davol, Inc. | 1992-03-26 |
| K910167 | MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM | Microbio-Medics, Inc. | 1991-04-15 |
| K905733 | SEROMA-CATH CLOSE DRAINAGE SYSTEM | Dawn Medical | 1991-01-28 |
| K901764 | INAMED CONVERTIBLE DRAIN SYSTEM | Inamed Development Co. | 1990-05-07 |
| K901742 | INAMED SMALL DRAIN SYSTEM | Inamed Development Co. | 1990-05-07 |
| K896491 | INAMED CLOSED-WOUND DRAIN SYSTEM | Inamed Development Co. | 1990-01-08 |
| K896803 | CLOSED WOUND RESERVOIR | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 |
| K883982 | DRENOVAC | Iberhospitex, S.A. | 1989-02-23 |
| K883472 | CLOSED WOUND SUCTION DEVICE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1988-10-18 |
| K883433 | AMBU TWIN PUMP - (MANUAL SUCTION PUMP) | Ambu, Inc. | 1988-09-02 |
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| 10080196966219 | Medline | MEDLINE INDUSTRIES, INC. | 2023-09-14 |
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| 08034139293974 | Drentech Closed Silicone Reservoir 400 ml | REDAX SPA | 2021-05-04 |
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| 08034139290614 | Drentech Pump 100 ml Flat Drainage 4x10 mm | REDAX SPA | 2021-05-04 |
| 08034139290638 | Silicone Reservoir 200 ml | REDAX SPA | 2021-05-04 |
| 08034139290645 | Silicone Reservoir 400 ml | REDAX SPA | 2021-05-04 |
| 08034139290805 | Drentech Pump 100 ml Flat Drainage 3x7 mm w/trocar | REDAX SPA | 2021-05-04 |
| 08034139290812 | Drentech Pump 100 ml Flat Drainage w/trocar 4x10 mm | REDAX SPA | 2021-05-04 |
| 08034139290843 | Drentech Pump 400 ml Round Drainage w/trocar Fr 19 | REDAX SPA | 2021-05-04 |
| 08034139291598 | Drentech Bag - Replacement | REDAX SPA | 2021-05-04 |
| 08034139290577 | Silicone Reservoir 100ml | REDAX SPA | 2020-10-21 |
| 08034139290584 | 100 ml Bulb and JP Flat 3/4 fenestration 3 x 7 mm | REDAX SPA | 2020-10-21 |
| H862TCS10000 | Tru-Close Suction Drainage System | URESIL, LLC | 2017-09-11 |
| H862TCS300D0 | Tru-Close Suction Drainage System | URESIL, LLC | 2017-09-11 |
| H862TCS5000 | Tru-Close Suction Drainage System | URESIL, LLC | 2017-09-11 |
| H862TCS500D0 | Tru-Close Suction Drainage System | URESIL, LLC | 2017-09-11 |
| H862TCS500DS0 | Tru-Close Suction Drainage System | URESIL, LLC | 2017-09-11 |
| H862TCY20 | Tru-Close Suction Drainage System | URESIL, LLC | 2017-09-11 |