Cleared Traditional

K960219 - PROLEX MESH

K960219 is an FDA 510(k) clearance for PROLEX MESH, manufactured by Advanced Surgical Innovations, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K960219 · Advanced Surgical Innovations, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
59d
Days
Class 2
Risk

K960219 is an FDA 510(k) clearance for the PROLEX MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Advanced Surgical Innovations, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on March 15, 1996 after a review of 59 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 Advanced Surgical Innovations, Inc. devices

FDA 510(k) Submission Details - K960219

510(k) Number K960219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date March 15, 1996
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
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 K960219.
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
K962530 · Ethicon, Inc. · Aug 1996
SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH
K961440 · Fusion Medical Technologies, Inc. · May 1996
SOFT TISSUE AUGMENTATION TUBE
K960481 · Tissue Technologies, Inc. · Apr 1996
GLYCAR STAPLE STRIPS
K954665 · Glycar, Inc. · Feb 1996
GORE-TEX DUALMESH BIOMATERIAL WITH HOLES
K955494 · W.L. Gore & Associates, Inc. · Jan 1996
GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER
K952898 · W.L. Gore & Associates, Inc. · Nov 1995