K924713 is an FDA 510(k) clearance for the UNIVERSAL SURGICAL INSTRUMENT HOLDER. This device is classified as a Table, Operating-room, Pneumatic (Class I - General Controls, product code FWW).
Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on May 17, 1993, 241 days after receiving the submission on September 18, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.
| 510(k) Number | K924713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1992 |
| Decision Date | May 17, 1993 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FWW — Table, Operating-room, Pneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4960 |