K930205 is an FDA 510(k) clearance for the ELECTRIC WIRE DRIVER, MODEL 2640E. This device is classified as a Staple Driver (Class I - General Controls, product code HXJ).
Submitted by Micro Surgical Instruments Corp. (Valencia, US). The FDA issued a Cleared decision on August 2, 1993, 199 days after receiving the submission on January 15, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K930205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 1993 |
| Decision Date | August 02, 1993 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HXJ — Staple Driver |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |