510(k) K250314 ยท PNE Reprocessed Catheter Introducer
Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
| Applicant | Surgical Instrument Service and Savings, Inc., Redmond OR, US |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Feb 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250314
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.