510(k) K183581 ยท HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Codman Disposable Perforators
| Applicant | Integra Lifesciences Corp., Mansfield MA, US |
| Decision | Substantially Equivalent, Jan 20, 2019 |
| Received | Dec 21, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Disposable Perforator 11mm. Cranial Perforator. Open, Classified |
HBF | None listed |
| Nov 3, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Disposable Perforator 9mm. Cranial Perforator. Open, Classified |
HBF | None listed |
| May 6, 2025 | Integra LifeSciences Corp. (NeuroSciences) CODMAN Disposable Perforator, 14mm. Cranial perforator. Open, Classified |
HBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.