Cleared Traditional

K052643 - EPICERAM

K052643 · Ceragenix Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
197d
Days
-
Risk

K052643 is an FDA 510(k) clearance for the EPICERAM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Ceragenix Corporation (Denver, US). The FDA issued a Cleared decision on April 11, 2006 after a review of 197 days - an extended review 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: 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 - K052643

510(k) Number K052643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2005
Decision Date April 11, 2006
Days to Decision 197 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
82d slower than avg
Panel avg: 115d · This submission: 197d
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 708
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K052643.
CMB ANTIMICROBIAL DRESSING
K060237 · Silverleaf Medical Products, Inc. · Jun 2006
EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
K050032 · Euromed, Inc. · May 2006
COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING
K060804 · Covalon Technologies, Ltd. · Apr 2006
TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
K051542 · Triosyn Corp. · Mar 2006
DERMACYN WOUND CARE
K060113 · Oculus Innovative Sciences, Inc. · Feb 2006
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
K050086 · Brennen Medical, Inc. · Feb 2006
K052643 · EPICERAM
Download PDF FDA Summary Ceragenix Corporation