510(k) K142979 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters
| Applicant | Smith & Nephew, Inc., St Petersburg FL, US |
| Decision | Substantially Equivalent, Apr 29, 2015 |
| Received | Oct 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142979
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2016 | Smith & Nephew, Inc. RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film
Is intended for patients who would benefit from a suction device (negative pressur Open, Classified |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.