510(k) K233710

Device

Symphion Operative Hysteroscopy System

Applicant

Minerva Surgical, Inc.

510(k) number

K233710

Product code

PGT

Decision

Substantially Equivalent (SESE)

Decision date

2024-01-17

Date received

2023-11-20

Regulation

884.1710

Classification name

Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

Medical specialty

Obstetrics/Gynecology

Review panel

Obstetrics/Gynecology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No