Cleared Traditional

K962530 - PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH

K962530 is an FDA 510(k) clearance for PROLENE POLYPROPYLENE MESH NONABSORBABL..., manufactured by Ethicon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K962530 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
42d
Days
Class 2
Risk

K962530 is an FDA 510(k) clearance for the PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH. 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 August 9, 1996 after a review of 42 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. 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 Ethicon, Inc. devices

FDA 510(k) Submission Details - K962530

510(k) Number K962530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1996
Decision Date August 09, 1996
Days to Decision 42 days
Submission Type Traditional
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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 267
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K962530.
POLYPROPYLENE MESH (VARIOUS SIZES)
K962971 · Davis & Geck, Inc. · Sep 1996
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K962401 · W.L. Gore & Associates, Inc. · Sep 1996
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
K962496 · Tissue Technologies, Inc. · Sep 1996
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
K961440 · Fusion Medical Technologies, Inc. · May 1996
SOFT TISSUE AUGMENTATION TUBE
K960481 · Tissue Technologies, Inc. · Apr 1996
PROLEX MESH
K960219 · Advanced Surgical Innovations, Inc. · Mar 1996