K944590 is an FDA 510(k) clearance for the ETHICON DRILL BIT AND DRILL GUIDE. This device is classified as a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I - General Controls, product code HSZ).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on May 11, 1995, 234 days after receiving the submission on September 19, 1994.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K944590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1994 |
| Decision Date | May 11, 1995 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |