Cleared Special

K122436 - COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM

K122436 is an FDA 510(k) clearance for COMPOSIX L/P MESH WITH ECHO PS POSITION..., manufactured by C.R. Bard, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Special 510(k) pathway after a 84-day FDA review.

K122436 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
84d
Days
Class 2
Risk

K122436 is an FDA 510(k) clearance for the COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH EC.... Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on November 2, 2012 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery 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 - K122436

510(k) Number K122436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2012
Decision Date November 02, 2012
Days to Decision 84 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 336
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K122436.
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K130968 · C.R. Bard, Inc. · May 2013
MEDLINX SURGICAL MESH
K120844 · Medlinx Acala Pte, Ltd. · Dec 2012
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
K123479 · Sofradim Production · Dec 2012
FREEDOM INGUINAL HERNIA IMPLANT
K113552 · Insightra Medical · Aug 2012
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING
K113229 · C.R. Bard, Inc. · Jul 2012
TIO2MESH TM
K113311 · Biocer Entwicklungs GmbH · Jul 2012
K122436 · COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
Download PDF FDA Summary C.R. Bard, Inc.