510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130040Unknown

Iogyn System

Iogyn, Inc., Cupertino CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN130040 is the FDA 510(k) clearance record for IOGYN SYSTEM, a class II device, cleared for Iogyn, 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 2 510(k) clearances for Iogyn, Inc., from to . As of , FDA records show no recalls naming DEN130040.

Clearance record

Decision date
Received
(210 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
Iogyn, Inc. 20195 Stevens Creek Blvd., Cupertino CA
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