Cleared Traditional

K022416 - CONTREET FOAM ADHESIVE/NON-ADHESIVE

K022416 · Coloplast Corp. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Coloplast Corp. devices

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 457
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K022416.
ANTIMICROBIAL ALGINATE DRESSING
K041316 · Advanced Medical Solutions, Ltd. · Aug 2004
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
K033869 · Coloplast Corp. · May 2004
FERRIS POLYMEM SILVER WOUND DRESSING
K031307 · Ferris Mfg. Corp. · Oct 2003
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
K012816 · Dynarex Corp. · Oct 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · Convatec, A Division of E.R. Squibb & Sons · Jun 2002
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
K992221 · Westaim Biomedical, Inc. · Jun 2000