Peri-Guard and Supple Peri-Guard
FDA 510(k) clearance K223052 · decided 2023-04-07
Clearance details
- K-number
- K223052
- Device name
- Peri-Guard and Supple Peri-Guard
- Applicant
- Synovis Life Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-29
- Decision date
- 2023-04-07
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- FTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG recall (Z-1379-2024) | Baxter Healthcare Corporation | 2024-03-26 |
| Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0 recall (Z-1380-2024) | Baxter Healthcare Corporation | 2024-03-26 |
| Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS recall (Z-0665-2024) | Baxter Healthcare Corporation | 2024-01-05 |
| PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS recall (Z-0668-2024) | Baxter Healthcare Corporation | 2024-01-05 |