K900894 is an FDA 510(k) clearance for the MEDILASE SERIES 2100 ENDOSCOPE. This device is classified as a Endoscope, Flexible (Class II - Special Controls, product code GCQ).
Submitted by Medical Laser, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 22, 1990, 115 days after receiving the submission on February 27, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K900894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1990 |
| Decision Date | June 22, 1990 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | GCQ — Endoscope, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |