Cleared Traditional

K100693 - AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING

K100693 · Medtrade Products Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
152d
Days
-
Risk

K100693 is an FDA 510(k) clearance for the AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medtrade Products Limited (Crewe, Cheshire, GB). The FDA issued a Cleared decision on August 10, 2010 after a review of 152 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 Medtrade Products Limited devices

FDA 510(k) Submission Details - K100693

510(k) Number K100693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2010
Decision Date August 10, 2010
Days to Decision 152 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
37d slower than avg
Panel avg: 115d · This submission: 152d
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 607
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K100693.
OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING
K102478 · Southwest Technologies, Inc. · Nov 2010
EXSALT WOUND DRESSING
K100580 · Exciton Technologies, Inc. · Oct 2010
MEPILEX BORDER AG DRESSING
K100029 · Molnlycke Health Care · Sep 2010
VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014
K100918 · Puricore, Inc. · Aug 2010
TALYMED
K102002 · Marine Polymer Technologies · Jul 2010
PRUCLAIR NONSTEROIDAL CREAM
K093156 · Prugen IP Holdings, Inc. · Jun 2010