K810569 is an FDA 510(k) clearance for the CONTACT-MICRO COLPOHYSTEROSCOPE. This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by KARL STORZ Endoscopy-America, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981, 135 days after receiving the submission on March 3, 1981.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K810569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 1981 |
| Decision Date | July 16, 1981 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |