Cleared Traditional

K112357 - VESSEL GUARDIAN

K112357 is an FDA 510(k) clearance for VESSEL GUARDIAN, manufactured by Lexion Medical, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K112357 · Lexion Medical, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
86d
Days
Class 2
Risk

K112357 is an FDA 510(k) clearance for the VESSEL GUARDIAN. 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 November 10, 2011 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lexion Medical, LLC devices

FDA 510(k) Submission Details - K112357

510(k) Number K112357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2011
Decision Date November 10, 2011
Days to Decision 86 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
74d faster than avg
Panel avg: 160d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K112357.
CARBONAID C02 DIFFUSER
K112975 · Cardia Innovation AB · Jun 2012
HIGH FLOW INSUFFLATION UNIT UHI-4
K110294 · Olympus Medical Systems Corporation · Nov 2011
MEDLINE PNEUMOPERITONEUM NEEDLE
K111955 · Medline Industries, Inc. · Nov 2011
UNIMAX VERESS NEEDLE
K111441 · Unimax Medical Systems, Inc. · Aug 2011
SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
K103692 · Surgiquest, Inc. · May 2011
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K080852 · KARL STORZ Endoscopy-America, Inc. · Mar 2009