510(k) K953655 ยท OCX Endoscopic Irrigation/Suction System
J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS
| Applicant | Johnson & Johnson Medical, Inc., Arlington TX, US |
| Decision | Substantially Equivalent, Oct 13, 1995 |
| Received | Aug 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953655
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2011 | Ethicon, Inc. Blake Silicone Drain, 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151.
Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate Terminated |
KOG | None listed |
| Jul 7, 2011 | Ethicon, Inc. Blake Silicone Drain Kit Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151.
Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potent Terminated |
KOG | None listed |
| Jul 7, 2011 | Ethicon, Inc. J-Vac Bulb Suction Reservoir, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151.
Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate Terminated |
KOG | None listed |
| Jul 7, 2011 | Ethicon, Inc. Blake Cardio Connector 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151.
Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate Terminated |
KOG | None listed |
| Jul 7, 2011 | Ethicon, Inc. J-Vac Drain Adaptor Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151.
Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentiall Terminated |
KOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.