Cleared Traditional

K121134 - TL TRISEB CREAM

K121134 · Trigen Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
103d
Days
-
Risk

K121134 is an FDA 510(k) clearance for the TL TRISEB CREAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Trigen Laboratories, Inc. (Riverview, US). The FDA issued a Cleared decision on July 25, 2012 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K121134

510(k) Number K121134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2012
Decision Date July 25, 2012
Days to Decision 103 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
12d faster than avg
Panel avg: 115d · This submission: 103d
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 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K121134.
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K113820 · Novabay Pharmaceuticals · Aug 2012
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K121134 · TL TRISEB CREAM
Download PDF FDA Summary Trigen Laboratories, …