510(k) K253620 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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| Applicant | Gordian Surgical, Ltd., Misgav, IL |
| Decision | Substantially Equivalent, Dec 16, 2025 |
| Received | Nov 18, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253620
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.