Cleared Traditional

SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.) (K962496) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962496 · Tissue Technologies, Inc. · General & Plastic Surgery device
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Sep 1996
Decision
69d
Days
Class 2
Risk

K962496 is an FDA 510(k) clearance for the SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.). Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Tissue Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on September 3, 1996 after a review of 69 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 Tissue Technologies, Inc. devices

Submission Details

510(k) Number K962496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1996
Decision Date September 03, 1996
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 131
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K962496.
SURGICAL FABRICS
K963226 · Boston Scientific Corp · Nov 1996
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
K963619 · W.L. Gore & Associates, Inc. · Oct 1996
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K962401 · W.L. Gore & Associates, Inc. · Sep 1996
PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH
K962530 · Ethicon, Inc. · Aug 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