K192822 is an FDA 510(k) clearance for the Benesta Hysteroscope. This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on September 9, 2020, 344 days after receiving the submission on October 1, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K192822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2019 |
| Decision Date | September 09, 2020 |
| Days to Decision | 344 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |