# K233710: Symphion Operative Hysteroscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Minerva Surgical, Inc.
- Decided: Jan 17, 2024 after 58 days
- Product code: PGT (Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar)
- Device class: 2
- Regulation: 21 CFR 884.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K950035 (1996). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141848: Iogyn System, Iogyn, Inc. (2014) Summary page 5.
- K180825: Fluent Fluid Management System, Hologic, Inc. (2018) Summary page 5.

## Indications for use
The Symphion Operative Hysteroscopy System and accessories are intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device by distending the uterus with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and providing fluid management through either the closed loop recirculation of filtered distension fluid or non-recirculating/non-filtered distension fluid.

Source page: https://510kreport.com/device/K233710
Methodology: https://510kreport.com/methodology