K933921 is an FDA 510(k) clearance for the ACUFLEX DISPOSABLE KNIVES. This device is classified as a Knife, Orthopedic (Class I - General Controls, product code HTS).
Submitted by Acufex Microsurgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on January 26, 1994, 169 days after receiving the submission on August 10, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K933921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1993 |
| Decision Date | January 26, 1994 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HTS — Knife, Orthopedic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |