K862689 is an FDA 510(k) clearance for the 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP. This device is classified as a Screwdriver (Class I - General Controls, product code HXX).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on September 2, 1986, 49 days after receiving the submission on July 15, 1986.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K862689 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1986 |
| Decision Date | September 02, 1986 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HXX — Screwdriver |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |