Cleared Special

K130817 - LTN - LAPAROSCOPIC SURGICAL MESH (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130817 · Lifecell Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
23d
Days
Class 2
Risk

K130817 is an FDA 510(k) clearance for the LTN - LAPAROSCOPIC SURGICAL MESH. Classified as Mesh, Surgical, Collagen, Large Abdominal Wall Defects (product code OXK), Class II - Special Controls.

Submitted by Lifecell Corp. (Branchburg, US). The FDA issued a Cleared decision on April 17, 2013 after a review of 23 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 Lifecell Corp. devices

Submission Details

510(k) Number K130817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2013
Decision Date April 17, 2013
Days to Decision 23 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 114d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists In Abdominal Wall Defects.
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.