Cleared Traditional

K061060 - TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8

K061060 · 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
Jul 2006
Decision
77d
Days
-
Risk

K061060 is an FDA 510(k) clearance for the TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Tissue Technologies Holdings, LLC (Richmond, US). The FDA issued a Cleared decision on July 3, 2006 after a review of 77 days - a notably fast clearance cycle.

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: 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 - K061060

510(k) Number K061060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2006
Decision Date July 03, 2006
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K061060.
ALGICELL AG
K052536 · Derma Sciences Canada, Inc. · Sep 2006
AGCEL WOUND DRESSING,AGCEL BURN DRESSING
K050842 · Modern Medical Equipment Mfg., Ltd. · Aug 2006
URGOTUL AG
K061220 · Laboratoires Urgo · Jul 2006
VASHE WOUND CLEANSING SYSTEM
K060901 · Sterilox Technologies, Inc. · Jun 2006
CMB ANTIMICROBIAL DRESSING
K060237 · Silverleaf Medical Products, Inc. · Jun 2006
EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
K050032 · Euromed, Inc. · May 2006
K061060 · TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8
Download PDF FDA Summary Tissue Technologies H…