Not Cleared Direct

DEN130040 - IOGYN SYSTEM (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN130040 · Iogyn, Inc. · Obstetrics & Gynecology device
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Mar 2014
Decision
210d
Days
Class 2
Risk

DEN130040 is an FDA 510(k) submission (not cleared) for the IOGYN SYSTEM. Classified as Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar (product code PGT), Class II - Special Controls.

Submitted by Iogyn, Inc. (Cupertino, US). The FDA issued a Not Cleared (DENG) decision on March 28, 2014 after a review of 210 days.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1710 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Obstetrics & Gynecology review framework.

View all Iogyn, Inc. devices

Submission Details

510(k) Number DEN130040 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 30, 2013
Decision Date March 28, 2014
Days to Decision 210 days
Submission Type Direct
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 160d · This submission: 210d
Pathway characteristics

Device Classification

Product Code PGT Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1710
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.