Cleared Traditional

AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K080383) - FDA 510(k) Clearance

K080383 · Convatec, A Division of E.R. Squibb & Sons, LLC · General & Plastic Surgery device
Download Printable Device Report (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.

View all Convatec, A Division of E.R. Squibb & Sons, LLC devices

Submission Details

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
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 701
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K080383.
StatSeal Disc
K254073 · Merit Medical Systems, Inc. · May 2026
IWD-Gel™
K254191 · InnovaCorium, Inc. · Apr 2026
MiraChlor Antimicrobial Wound Solution
K252023 · Letus Corporation · Mar 2026
Promogran Prisma™ Collagen Matrix with ORC and Silver
K251999 · Solventum Germany GmbH · Mar 2026
LUOFUCON® Antimicrobial Wound Gel
K252028 · Huizhou Foryou Medical Co., Ltd. · Mar 2026
Redermax Antibacterial Wound Matrix
K251582 · Beijing Kreate Medical Co., Ltd. · Feb 2026