Cleared Special

K141848 - IOGYN SYSTEM (FDA 510(k) Clearance)

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

K141848 · Iogyn, Inc. · Obstetrics & Gynecology device
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Aug 2014
Decision
51d
Days
Class 2
Risk

K141848 is an FDA 510(k) clearance 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 Cleared decision on August 29, 2014 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1710 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Iogyn, Inc. devices

Submission Details

510(k) Number K141848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2014
Decision Date August 29, 2014
Days to Decision 51 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 160d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

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.