510(k) K233710
K233710 is an FDA 510(k) premarket notification submitted by Minerva Surgical, Inc. for the device "Symphion Operative Hysteroscopy System". The FDA issued a decision of Substantially Equivalent on January 17, 2024. The device falls under product code PGT (Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar), a Class II device regulated under 21 CFR 884.1710.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2024
- Date Received
- November 20, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
- Device Class
- Class II
- Regulation Number
- 884.1710
- Review Panel
- OB
- Submission Type
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.