510(k) K083375 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
| Applicant | Smith & Nephew, Inc., St Petersburg FL, US |
| Decision | Substantially Equivalent, Feb 25, 2009 |
| Received | Nov 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2016 | Smith & Nephew, Inc. Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only.
Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigat Open, Classified |
OMP | None listed |
| Nov 11, 2016 | Smith & Nephew, Inc. Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only.
Intended for patients who would benefit from a suction device to help promote wound healing by removin Open, Classified |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.