K193346 is an FDA 510(k) clearance for the Codman Surgical Patties & Strips. This device is classified as a Neurosurgical Paddie (Class II - Special Controls, product code HBA).
Submitted by Integra LifeSciences Corporation (Mansfield, US). The FDA issued a Cleared decision on November 20, 2020, 353 days after receiving the submission on December 3, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4700.
| 510(k) Number | K193346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2019 |
| Decision Date | November 20, 2020 |
| Days to Decision | 353 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBA — Neurosurgical Paddie |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4700 |