510(k) K091315 ยท FMF Syringe, Piston
COVIDIEN EXTENDED TIP APPLICATOR
| Applicant | Confluent Surgical,Inc, Waltham MA, US |
| Decision | Substantially Equivalent, Jun 5, 2009 |
| Received | May 4, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091315
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) Extended Tip Applicator, 8CM, Box of 5. Open, Classified |
FMF | None listed |
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) Extended Tip Applicator, 15 CM, Box of 5. Open, Classified |
FMF | None listed |
| Jun 20, 2025 | Integra LifeSciences Corp. (NeuroSciences) Extended Tip Applicator 8CM, Box of 1. Open, Classified |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.