Renasys Edge (66803126)
FDA 510(k) clearance K223041 · decided 2022-11-22
Clearance details
- K-number
- K223041
- Device name
- Renasys Edge (66803126)
- Applicant
- Smith & Nephew Medical Limited
- Decision
- Substantially Equivalent
- Date received
- 2022-09-29
- Decision date
- 2022-11-22
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hull, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suct recall (Z-0516-2025) | Smith & Nephew Medical, Ltd. | 2024-11-22 |
| RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from recall (Z-1596-2024) | Smith & Nephew Medical, Ltd. | 2024-04-18 |
| RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from recall (Z-1597-2024) | Smith & Nephew Medical, Ltd. | 2024-04-18 |