Cleared Traditional

K011994 - ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101

K011994 · Acrymed, Inc. · General & Plastic Surgery device
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Nov 2001
Decision
135d
Days
-
Risk

K011994 is an FDA 510(k) clearance for the ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Acrymed, Inc. (Portland, US). The FDA issued a Cleared decision on November 8, 2001 after a review of 135 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 Acrymed, Inc. devices

FDA 510(k) Submission Details - K011994

510(k) Number K011994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2001
Decision Date November 08, 2001
Days to Decision 135 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 98
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K011994.
COLLATEK HYDROGEL
K022995 · Biocore Medical Technologies, Inc. · Dec 2002
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)
K013525 · Coloplast Corp. · Oct 2002
L.A.M. IPM WOUND GEL
K020325 · L.A.M. Pharmaceutical, Corp. · Apr 2002
AMBU GEL, HYDROGEL BURN DRESSING
K010583 · Ambu, Inc. · May 2001
DIAMOND ALOE VERA, STERILE
K002666 · Medi-Tech Intl. Corp. · Feb 2001
BURN JEL PLUS
K003396 · Water-Jel Technologies, LLC · Jan 2001