K941605 is an FDA 510(k) clearance for the STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH. This device is classified as a Orthopedic Manual Surgical Instrument (Class I - General Controls, product code LXH).
Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on August 5, 1994, 126 days after receiving the submission on April 1, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K941605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1994 |
| Decision Date | August 05, 1994 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | LXH — Orthopedic Manual Surgical Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |