Cleared Special

K141848 - IOGYN SYSTEM

K141848 is an FDA 510(k) clearance for IOGYN SYSTEM, manufactured by Iogyn, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code PGT cleared through the Special 510(k) pathway after a 51-day FDA review.

K141848 · Iogyn, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K141848

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 161d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

PGT Device Classification - Class 2, Special Controls

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.

K141848 · IOGYN SYSTEM
Download PDF FDA Summary Iogyn, Inc.