Submission Details
| 510(k) Number | K183581 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 21, 2018 |
| Decision Date | January 20, 2019 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Special
Codman Disposable Perforators
Jan 2019
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K183581 is an FDA 510(k) clearance for the Codman Disposable Perforators, a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II — Special Controls, product code HBF), submitted by Integra Lifesciences Corp. (Mansfield, US). The FDA issued a Cleared decision on January 20, 2019, 30 days after receiving the submission on December 21, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4305.
Device Classification
| Product Code | HBF — Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4305 |
Manufacturer
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