Cleared Traditional

K033869 - CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)

K033869 · Coloplast Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
157d
Days
-
Risk

K033869 is an FDA 510(k) clearance for the CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coloplast Corp. (North Mankato, US). The FDA issued a Cleared decision on May 17, 2004 after a review of 157 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 - K033869

510(k) Number K033869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2003
Decision Date May 17, 2004
Days to Decision 157 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
42d slower than avg
Panel avg: 115d · This submission: 157d
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 K033869.
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FERRIS POLYMEM SILVER WOUND DRESSING
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K022416 · Coloplast Corp. · Feb 2003
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K012816 · Dynarex Corp. · Oct 2002