Cleared Traditional

K002071 - SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES

K002071 is an FDA 510(k) clearance for SOFTFORM SOFT TISSUE AUGMENTATION TUBE ..., 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 17-day FDA review.

K002071 · Tissue Technologies, Inc. · General & Plastic Surgery device
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Jul 2000
Decision
17d
Days
Class 2
Risk

K002071 is an FDA 510(k) clearance for the SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR .... 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 July 24, 2000 after a review of 17 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.

FDA 510(k) Submission Details - K002071

510(k) Number K002071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2000
Decision Date July 24, 2000
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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 335
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K002071.
BIOMESH P1 AND BIOMESH PLUG AND PATCH
K002479 · Cousin Biotech S.A.R.L · Oct 2000
COMPOSIX E/X MESH
K002684 · C.R. Bard, Inc. · Oct 2000
FLUOROTEX II SURGICAL MESH
K002351 · Bridger Biomed, Inc. · Aug 2000
ATRIUM LITE MESH
K002093 · Atrium Medical Corp. · Jul 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122 · Ethicon, Inc. · May 2000
SOFTFORM FACIAL IMPLANT
K000849 · Tissue Technologies, Inc. · May 2000
K002071 · SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
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