K923689 is an FDA 510(k) clearance for the SURGISTAR BLADES. This device is classified as a Scalpel, One-piece (Class I — General Controls, product code GDX).
Submitted by Surgistar, Inc. (Vista, US). The FDA issued a Cleared decision on September 9, 1992, 47 days after receiving the submission on July 24, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K923689 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 1992 |
| Decision Date | September 09, 1992 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDX — Scalpel, One-piece |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |