510(k) K223041 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Renasys Edge (66803126)
| Applicant | Smith & Nephew Medical Limited, Hull, GB |
| Decision | Substantially Equivalent, Nov 22, 2022 |
| Received | Sep 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223041
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2024 | Smith & Nephew Medical, Ltd. RENASYS EDGE
The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body Open, Classified |
OMP | None listed |
| Apr 18, 2024 | Smith & Nephew Medical, Ltd. RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing.
Product Number: 66803139 Open, Classified |
OMP | None listed |
| Apr 18, 2024 | Smith & Nephew Medical, Ltd. RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing
Product Number: 66803140 Open, Classified |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.