510(k) K082426 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS EZ
| Applicant | Smith & Nephew, Inc., St Petersburg FL, US |
| Decision | Substantially Equivalent, Sep 5, 2008 |
| Received | Aug 22, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082426
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 8, 2014 | Smith & Nephew, Inc. RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier
Product Usage:
RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negativ Terminated |
OMP | None listed |
| Oct 8, 2014 | Smith & Nephew, Inc. RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier
Product Usage:
RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negativ Terminated |
OMP | None listed |
| Oct 8, 2014 | Smith & Nephew, Inc. RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier
Product Usage:
RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated Terminated |
OMP | None listed |
| Sep 23, 2014 | Smith & Nephew, Inc. RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing. Terminated |
OMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.