K864314 is an FDA 510(k) clearance for the EFTEKHAR RECHANNELIZATION DRILL GUIDE. This device is classified as a Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (Class I - General Controls, product code HSZ).
Submitted by The Anspach Effort, Inc. (Lake Park, US). The FDA issued a Cleared decision on November 19, 1986, 16 days after receiving the submission on November 3, 1986.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K864314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1986 |
| Decision Date | November 19, 1986 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HSZ — Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |