K192811 is an FDA 510(k) clearance for the BenestaTM Tissue Removal Device, 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 October 23, 2020, 389 days after receiving the submission on September 30, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K192811 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2019 |
| Decision Date | October 23, 2020 |
| Days to Decision | 389 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1690 |