510(k) K983007 ยท JXI Cuff, Nerve
NEUROTUBE
| Applicant | Neuroregen, LLC, Bel Air MD, US |
| Decision | Substantially Equivalent, Mar 22, 1999 |
| Received | Aug 28, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983007
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2023 | Baxter Healthcare Corporation GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair Open, Classified |
JXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.