K201756 is an FDA 510(k) clearance for the Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent. This device is classified as a Hysteroscope (and Accessories) (Class II - Special Controls, product code HIH).
Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on September 25, 2020, 88 days after receiving the submission on June 29, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K201756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2020 |
| Decision Date | September 25, 2020 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIH — Hysteroscope (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1690 |