Cleared Traditional

K954665 - GLYCAR STAPLE STRIPS

K954665 is an FDA 510(k) clearance for GLYCAR STAPLE STRIPS, manufactured by Glycar, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K954665 · Glycar, Inc. · General & Plastic Surgery device
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Feb 1996
Decision
127d
Days
Class 2
Risk

K954665 is an FDA 510(k) clearance for the GLYCAR STAPLE STRIPS. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Glycar, Inc. (Dallas, US). The FDA issued a Cleared decision on February 14, 1996 after a review of 127 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Glycar, Inc. devices

FDA 510(k) Submission Details - K954665

510(k) Number K954665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1995
Decision Date February 14, 1996
Days to Decision 127 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
12d slower than avg
Panel avg: 115d · This submission: 127d
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 K954665.
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
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
GORE-TEX MYCROMESH BIOMATERIAL
K951675 · W.L. Gore & Associates, Inc. · Oct 1995