510(k) K223052 ยท FTM Mesh, Surgical
Peri-Guard and Supple Peri-Guard
| Applicant | Synovis Life Technologies, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Apr 7, 2023 |
| Received | Sep 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223052
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2024 | Baxter Healthcare Corporation Baxter Peri-Guard Repair Patch (new product codes):
a) PG0404,
b) PG0608,
c) PG0814,
d) PG1016,
e) PG1225 Open, Classified |
FTM | None listed |
| Mar 26, 2024 | Baxter Healthcare Corporation Baxter Supple Peri-Guard Repair Patch (new product codes):
a) SPG0404,
b) SPG0406,
c) SPG0608,
d) SPG0814,
e) SPG1016 Open, Classified |
FTM | None listed |
| Jan 5, 2024 | Baxter Healthcare Corporation Peri-Guard Repair Patch, Product Codes:
a) PC1016NBIO: 10X16CMUS,
b) PC1225NBIO: 12X25CMUS,
c) PC0404NBIO: 4X4CMUS,
d) PC0608NBIO: 6X8CMUS,
e) PC0814NBIO: 8X14CMUS Open, Classified |
FTM | None listed |
| Jan 5, 2024 | Baxter Healthcare Corporation PERI-GUARD SUPPLE, Product Codes:
a) SPG1016: 10X16 CM US, TS;
b) SPG0404: 4 X 4 CM US, TS;
c) SPG0608: 6 X 8 CM US, TS;
d) SPG0814: 8 X 14 CM US, TS;
e) PC1016SNBIO: 10X16 CM US;
f) PC0404 Open, Classified |
DXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.