Cleared Traditional

K022483 - ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING

K022483 · Johnson & Johnson Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
189d
Days
-
Risk

K022483 is an FDA 510(k) clearance for the ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Johnson & Johnson Medical, Ltd. (Somerville, US). The FDA issued a Cleared decision on February 3, 2003 after a review of 189 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.

View all Johnson & Johnson Medical, Ltd. devices

FDA 510(k) Submission Details - K022483

510(k) Number K022483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date February 03, 2003
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
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 607
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K022483.
SILVERLEAF CONTACT WOUND DRESSING
K013936 · Silverleaf Technologies, Inc. · Mar 2003
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
K020318 · Scivolutions, Inc. · Feb 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · Coloplast Corp. · Feb 2003
SILVERLON CONTACT WOUND DRESSING
K023612 · Argentum International, LLC · Jan 2003
HYDROFERA BACTERIOSTATIC WOUND DRESSING
K023138 · Hydrofera, LLC · Jan 2003
SILVERLON ADHESIVE STRIP
K023609 · Argentum International, LLC · Jan 2003