Cleared Traditional

K963175 - GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING

K963175 is an FDA 510(k) clearance for GLYCAR TISSUE REPAIR PATCH, manufactured by Glycar, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K963175 · Glycar, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
40d
Days
Class 2
Risk

K963175 is an FDA 510(k) clearance for the GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Glycar, Inc. (Dallas, US). The FDA issued a Cleared decision on September 23, 1996 after a review of 40 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 Glycar, Inc. devices

FDA 510(k) Submission Details - K963175

510(k) Number K963175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1996
Decision Date September 23, 1996
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 125
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K963175.
SURGISIS
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K973379 · S. Jackson, Inc. · Sep 1997
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K971048 · Bio-Vascular, Inc. · May 1997
SUPPLE PERI-GUARD PERICARDIUM
K961810 · Bio-Vascular, Inc. · Jun 1996
PERI-GUARD PERICARDIUM
K961811 · Bio-Vascular, Inc. · Jun 1996
PERI-STRIPS
K940205 · Bio-Vascular, Inc. · May 1994