Cleared Abbreviated

K100261 - PRIMATRIX AG ANTIMICROBIAL DERMAL DERMA...

K100261 · Tei Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
316d
Days
-
Risk

K100261 is an FDA 510(k) clearance for the PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on December 10, 2010 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Tei Biosciences, Inc. devices

FDA 510(k) Submission Details - K100261

510(k) Number K100261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2010
Decision Date December 10, 2010
Days to Decision 316 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 115d · This submission: 316d
Pathway characteristics
Standards-based clearance path.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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