K233710 is an FDA 510(k) clearance for the Symphion Operative Hysteroscopy System. This device is classified as a Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar (Class II - Special Controls, product code PGT).
Submitted by Minerva Surgical, Inc. (Santa Clara, US). The FDA issued a Cleared decision on January 17, 2024, 58 days after receiving the submission on November 20, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1710. To Distend The Uterus With Saline And Maintain Distension Through Closed-loop Recirculation Of Filtered Distension Fluid During Diagnostic And Operative Hysteroscopy. It Is Also Intended For Cutting And Coagulation Of Uterine Tissue..
| 510(k) Number | K233710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2023 |
| Decision Date | January 17, 2024 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PGT - Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1710 |
| Definition | To Distend The Uterus With Saline And Maintain Distension Through Closed-loop Recirculation Of Filtered Distension Fluid During Diagnostic And Operative Hysteroscopy. It Is Also Intended For Cutting And Coagulation Of Uterine Tissue. |