510(k) K980123 ยท GCJ Laparoscope, General & Plastic Surgery
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
| Applicant | Louisville Laboratories, Inc., Louisville KY, US |
| Decision | Substantially Equivalent, Mar 9, 1998 |
| Received | Jan 14, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980123
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2024 | CooperSurgical, Inc. Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Th Open, Classified |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.