Home › Device types › GCY
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
FDA product code GCY · Class 1 · General, Plastic Surgery
741
Registered devices
4,706
Adverse events
107
Recalls
96
510(k) clearances
Devices with this code
100 ml Bulb and JP Flat 3/4 fenestration 3 x 7 mm — REDAX SPABAROVAC® Evacuator Closed Wound Drainage System(SS) — Sewoon Medical Co., Ltd.Bioseal Inc. — BIOSEALClosed Wound Suction — C. R. Bard, Inc.Bioseal Inc. — BIOSEALBioseal Inc. — BIOSEALClosed Suction — SUNSET HEALTHCARE SOLUTIONS, INC.Silicone Reservoir 200 ml — REDAX SPAGreen Sprouts — O2cool, LLCBioseal Inc. — BIOSEALBioseal Inc. — BIOSEALBioseal Inc. — BIOSEALn.a. — VBM Medizintechnik GmbHNA — STRYKER CORPORATIONBioseal Inc. — BIOSEALExsudex disposable canister — Meditop B.V.Bioseal Inc. — BIOSEALDrentech Closed Silicone Reservoir 200 ml — REDAX SPACARDINAL HEALTH — Cardinal Health 200, LLCAspen® Discrete Drain — ASPEN SURGICAL PRODUCTS, INC.Closed Suction — SUNSET HEALTHCARE SOLUTIONS, INC.Bioseal Inc. — BIOSEALTru-Close Suction Drainage System — URESIL, LLCS-Vac® Perforated Drain — ASPEN SURGICAL PRODUCTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-05 | COVIDIEN LLC | The product was released into commercial distribution while subject to importation refusal. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk |
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