Cleared Traditional

K022584 - CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING

K022584 · Cardiotech Intl. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
147d
Days
-
Risk

K022584 is an FDA 510(k) clearance for the CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Cardiotech Intl. (Arvada, US). The FDA issued a Cleared decision on December 30, 2002 after a review of 147 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 - K022584

510(k) Number K022584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2002
Decision Date December 30, 2002
Days to Decision 147 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
32d slower than avg
Panel avg: 115d · This submission: 147d
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 144
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K022584.
MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS
K022587 · Medtrade Products , Ltd. · Aug 2003
SINCLAIR WOUND AND SKIN EMULSION
K024367 · Sinclair Pharmaceuticals, Ltd. · Jul 2003
XYLOS XCELL ANTIMICROBIAL DRESSING
K024054 · Xylos Corporation · Mar 2003
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
K022584 · CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
Download PDF FDA Summary Cardiotech Intl.