Cleared Traditional

K080383 - AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING

K080383 · Convatec, A Division of E.R. Squibb & Sons, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
80d
Days
-
Risk

K080383 is an FDA 510(k) clearance for the AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, A Division of E.R. Squibb & Sons, LLC (Skillman, US). The FDA issued a Cleared decision on May 2, 2008 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K080383

510(k) Number K080383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2008
Decision Date May 02, 2008
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
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 K080383.
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K080383 · AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
Download PDF FDA Summary Convatec, A Division …