Cleared Traditional

SKINTEMP, MODIFICATION (K925545) - FDA 510(k) Clearance

K925545 · Biocore · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
131d
Days
-
Risk

K925545 is an FDA 510(k) clearance for the SKINTEMP, MODIFICATION. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Biocore (Topeka, US). The FDA issued a Cleared decision on February 23, 1993 after a review of 131 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.

View all Biocore devices

Submission Details

510(k) Number K925545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1992
Decision Date February 23, 1993
Days to Decision 131 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 115d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -