Cleared Traditional

K120640 - INSUFLOW SYNERGY PORT

K120640 is the FDA 510(k) clearance for INSUFLOW SYNERGY PORT by Lexion Medical, LLC. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K120640 · Lexion Medical, LLC · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jul 2012
Decision
138d
Days
Class 2
Risk

K120640 is an FDA 510(k) clearance for the INSUFLOW SYNERGY 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 July 18, 2012 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lexion Medical, LLC devices

Submission Details

510(k) Number K120640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2012
Decision Date July 18, 2012
Days to Decision 138 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 160d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 81
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K120640.
ENDOFLATOR 40, ENDOFLATOR 50
K161554 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
HIGH FLOW INSUFFLANTION UNIT
K122180 · Olympus Medical Systems Corporation · Nov 2012
NEBULAE I
K120151 · Northgate Technologies, Inc. · Aug 2012
HIGH FLOW INSUFFLATION UNIT UHI-4
K110294 · Olympus Medical Systems Corporation · Nov 2011
MEDLINE PNEUMOPERITONEUM NEEDLE
K111955 · Medline Industries, Inc. · Nov 2011
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K080852 · KARL STORZ Endoscopy-America, Inc. · Mar 2009