510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233710Substantially Equivalent

Symphion Operative Hysteroscopy System

Minerva Surgical, Inc., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233710 is the FDA 510(k) clearance record for Symphion Operative Hysteroscopy System, a class II device, cleared for Minerva Surgical, Inc. on under FDA product code PGT (Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar). FDA's definition for product code PGT reads: "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". FDA records list one 510(k) clearance for Minerva Surgical, Inc. As of , FDA records show no recalls naming K233710.

Clearance record

Decision date
Received
(58 days to decision)
Product code
PGT Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
Regulation
21 CFR 884.1710
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Minerva Surgical, Inc. 4255 Burton Dr., Santa Clara CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGT

Trailing 12 months

FDA records hold no clearances under product code PGT in the trailing twelve months.

FDA records show no clearances under product code PGT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PGT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260