K930496 is an FDA 510(k) clearance for the GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS. This device is classified as a Laryngoscope, Endoscope (Class II - Special Controls, product code GCI).
Submitted by Birtcher Medical Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on April 20, 1993, 78 days after receiving the submission on February 1, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K930496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 1993 |
| Decision Date | April 20, 1993 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GCI — Laryngoscope, Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |