Codman Disposable Perforators
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183581 FDA 510(k)
- FDA Product Code
- HBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4305 FDA 510(k)
- Regulation Number
- 882.4305 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Codman Disposable Perforators are powered surgical instruments classified as drills, burrs, trephines, and accessories. These devices are designed specifically for perforating the cranium during neurosurgical procedures, providing controlled access to the brain while minimizing trauma to surrounding tissues.
These perforators are intended for single-use and are supplied sterile. They are regulated under FDA 510(k) clearance (K183581) as substantially equivalent to predicate devices, falling under classification II (HBF). Each perforator model is uniquely identified by its FEI number and registration number, ensuring traceability and compliance with regulatory standards. Storage and handling must adhere to sterile surgical instrument protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CODMAN® Disposable Perforator - Integra Life, PDF Disposable Perforators - Integra Life, PDF Codman® Disposable Perforators - Integra Life, Integra LifeSciences Recalls Codman Disposable Perforators, PDF URGENT - FIELD SAFETY NOTICE - RECALL CODMAN® Disposable Perforator ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183581 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA 510(k) K183581 24 fields · synced Oct 1, 2026