510(k) K102001 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
| Applicant | Smith & Nephew, Inc., St Petersburg FL, US |
| Decision | Substantially Equivalent, Aug 6, 2010 |
| Received | Jul 15, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102001
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.