Cleared Special

K071249 - ULTRAPRO* HERNIA SYSTEM

K071249 is the FDA 510(k) clearance for ULTRAPRO* HERNIA SYSTEM by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 32-day FDA review.

K071249 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
32d
Days
Class 2
Risk

K071249 is an FDA 510(k) clearance for the ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on June 5, 2007 after a review of 32 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.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K071249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2007
Decision Date June 05, 2007
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 185
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K071249.
PREVADH MESH
K073287 · Sofradim Production · Mar 2008
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
K071470 · Implantech Associates, Inc. · Aug 2007
PARIETEX POLYESTER MESH WITH INTRODUCER
K071629 · Sofradim Production · Jul 2007
TOPAS SYSTEM
K070993 · American Medical Systems, Inc. · May 2007
ULTRAPRO PLUG
K070224 · Ethicon, Inc. · Apr 2007
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
K070644 · W.L. Gore & Associates, Inc. · Apr 2007