510(k) K110647 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS GAUZE NPWT WOUND DRESSING KITS WITH SUCTION PAD; RENASYS
| Applicant | Smith & Nephew, Inc., St. Petersburg FL, US |
| Decision | Substantially Equivalent, Jun 22, 2011 |
| Received | Mar 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110647
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2014 | Smith & Nephew Inc. Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) Terminated |
OMP | None listed |
| Mar 10, 2014 | Smith & Nephew Inc. Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy Terminated |
OMP | None listed |
| Mar 10, 2014 | Smith & Nephew Inc. Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) Terminated |
OMP | None listed |
| Mar 10, 2014 | Smith & Nephew Inc. Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy Terminated |
OMP | None listed |
| Mar 10, 2014 | Smith & Nephew Inc. Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) Terminated |
OMP | None listed |
| Mar 10, 2014 | Smith & Nephew Inc. Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.