Cleared Traditional

K073547 - ANASEPT ANTIMICROBIAL SKIN AND WOUND CL...

Also marketed or referenced as:
ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL
K073547 · Anacapa Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
127d
Days
-
Risk

K073547 is an FDA 510(k) clearance for the ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Anacapa Technologies, Inc. (San Dimas, US). The FDA issued a Cleared decision on April 23, 2008 after a review of 127 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 Anacapa Technologies, Inc. devices

FDA 510(k) Submission Details - K073547

510(k) Number K073547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2007
Decision Date April 23, 2008
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
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 239
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K073547.
PRONTOSAN ANTIMICROBIAL WOUND GEL
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K071552 · Medline Industries, Inc. · Apr 2008
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc. · Nov 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007