Cleared Traditional

K973462 - SOFTFORM FACIAL IMPLANT

K973462 is an FDA 510(k) clearance for SOFTFORM FACIAL IMPLANT, manufactured by Tissue Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K973462 · Tissue Technologies, Inc. · General & Plastic Surgery device
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Nov 1997
Decision
73d
Days
Class 2
Risk

K973462 is an FDA 510(k) clearance for the SOFTFORM FACIAL IMPLANT. 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 November 24, 1997 after a review of 73 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

FDA 510(k) Submission Details - K973462

510(k) Number K973462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1997
Decision Date November 24, 1997
Days to Decision 73 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
42d faster than avg
Panel avg: 115d · This submission: 73d
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 224
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K973462.
HERNIAMESH SURGICAL MESHES
K973955 · Herniamesh · May 1998
MENTOR SUSPEND SLING
K980483 · Mentor Corp. · Apr 1998
SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES
K981051 · W.L. Gore & Associates, Inc. · Apr 1998
VENTRAL WALL DEFECT REDUCTION SILO
K973082 · Specialty Surgical Products, Inc. · Nov 1997
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
K972412 · Ethicon, Inc. · Sep 1997
BARD COMPOSITE PROSTHESIS
K971745 · Davol Inc., Sub. C. R. Bard, Inc. · Aug 1997