Cleared Special

K140263 - INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT

K140263 is an FDA 510(k) clearance for INSUFLOW SYNERGY 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 30-day FDA review.

K140263 · Lexion Medical, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
30d
Days
Class 2
Risk

K140263 is an FDA 510(k) clearance for the INSUFLOW SYNERGY PORT, 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 March 5, 2014 after a review of 30 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.

FDA 510(k) Submission Details - K140263

510(k) Number K140263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2014
Decision Date March 05, 2014
Days to Decision 30 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
131d faster than avg
Panel avg: 161d · This submission: 30d
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 178
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K140263.
Unimicro Veress Needle
K150068 · Unimicro Medical Systems (Shenzhen) Co., Ltd. · Jul 2015
SurgiQuest AirSeal iFS System
K143404 · Surgiquest, Inc. · Mar 2015
InsufflatOR Needle
K142700 · Gynetech Pty. , Ltd. · Dec 2014
PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
K132203 · Lexion Medical, LLC · Sep 2013
INSUFLOW SYNERGY XL PORT
K132204 · Lexion Medical, LLC · Aug 2013
HIGH FLOW INSUFFLANTION UNIT
K122180 · Olympus Medical Systems Corporation · Nov 2012
K140263 · INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
Download PDF FDA Summary Lexion Medical, LLC