Cleared Traditional

K022416 - CONTREET FOAM ADHESIVE/NON-ADHESIVE

K022416 · Coloplast Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
194d
Days
-
Risk

K022416 is an FDA 510(k) clearance for the CONTREET FOAM ADHESIVE/NON-ADHESIVE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coloplast Corp. (North Mankato, US). The FDA issued a Cleared decision on February 3, 2003 after a review of 194 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 - K022416

510(k) Number K022416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2002
Decision Date February 03, 2003
Days to Decision 194 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
79d slower than avg
Panel avg: 115d · This submission: 194d
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 709
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K022416.
ANTIMICROBIAL ALGINATE DRESSING
K024298 · Advanced Medical Solutions, Ltd. · Jun 2003
SILVERLEAF CONTACT WOUND DRESSING
K013936 · Silverleaf Technologies, Inc. · Mar 2003
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
K020318 · Scivolutions, Inc. · Feb 2003
ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING
K022483 · Johnson & Johnson Medical, Ltd. · Feb 2003
SILVERLON CONTACT WOUND DRESSING
K023612 · Argentum International, LLC · Jan 2003
HYDROFERA BACTERIOSTATIC WOUND DRESSING
K023138 · Hydrofera, LLC · Jan 2003
K022416 · CONTREET FOAM ADHESIVE/NON-ADHESIVE
Download PDF FDA Summary Coloplast Corp.