Cleared Special

K132204 - INSUFLOW SYNERGY XL PORT

K132204 is an FDA 510(k) clearance for INSUFLOW SYNERGY XL PORT, manufactured by Lexion Medical, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Special 510(k) pathway after a 37-day FDA review.

K132204 · Lexion Medical, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
37d
Days
Class 2
Risk

K132204 is an FDA 510(k) clearance for the INSUFLOW SYNERGY XL PORT. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Lexion Medical, LLC (St. Paul, US). The FDA issued a Cleared decision on August 22, 2013 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - 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 Lexion Medical, LLC devices

FDA 510(k) Submission Details - K132204

510(k) Number K132204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2013
Decision Date August 22, 2013
Days to Decision 37 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
123d faster than avg
Panel avg: 160d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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.

Regulatory Peers - HIF Insufflator, Laparoscopic

All 124
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K132204.
InsufflatOR Needle
K142700 · Gynetech Pty. , Ltd. · Dec 2014
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
K140263 · Lexion Medical, LLC · Mar 2014
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
K132203 · Lexion Medical, LLC · Sep 2013
HIGH FLOW INSUFFLANTION UNIT
K122180 · Olympus Medical Systems Corporation · Nov 2012
NEBULAE I
K120151 · Northgate Technologies, Inc. · Aug 2012
INSUFLOW SYNERGY PORT
K120640 · Lexion Medical, LLC · Jul 2012