Cleared Traditional

K081246 - TT-102

K081246 · Tissue Technologies Holdings, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
469d
Days
-
Risk

K081246 is an FDA 510(k) clearance for the TT-102. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Tissue Technologies Holdings, LLC (Richmond, US). The FDA issued a Cleared decision on August 13, 2009 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K081246

510(k) Number K081246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2008
Decision Date August 13, 2009
Days to Decision 469 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
354d slower than avg
Panel avg: 115d · This submission: 469d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 664
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K090791 · Century Pharmaceuticals, Inc. · Aug 2009
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K083334 · Southwest Technologies, Inc. · Jul 2009
K081246 · TT-102
Download PDF FDA Summary Tissue Technologies H…