K905117 is an FDA 510(k) clearance for the ENDOSCOPE AND ACCESSORIES. This device is classified as a Laryngoscope, Endoscope (Class II - Special Controls, product code GCI).
Submitted by Northgate Technologies, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on April 25, 1991, 163 days after receiving the submission on November 13, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K905117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1990 |
| Decision Date | April 25, 1991 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GCI — Laryngoscope, Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |