Cleared Special

K140483 - ASAP OTC WOUND DRESSING GEL

K140483 · Abl Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
83d
Days
-
Risk

K140483 is an FDA 510(k) clearance for the ASAP OTC WOUND DRESSING GEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Abl Medical, LLC (Alexandria, US). The FDA issued a Cleared decision on May 20, 2014 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140483

510(k) Number K140483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2014
Decision Date May 20, 2014
Days to Decision 83 days
Submission Type Special
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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K140483.
IONSIL GEL
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