K926037 is an FDA 510(k) clearance for the HARPOON SUTURE ANCHOR. This device is classified as a Staple, Fixation, Bone (Class II - Special Controls, product code JDR).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 5, 1993, 155 days after receiving the submission on December 1, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K926037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1992 |
| Decision Date | May 05, 1993 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDR — Staple, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |