Cleared Traditional

K130553 - ABSOCLEAR

K130553 · Pharmaplast S.A.E. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
121d
Days
-
Risk

K130553 is an FDA 510(k) clearance for the ABSOCLEAR. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Pharmaplast S.A.E. (Raleigh, US). The FDA issued a Cleared decision on July 3, 2013 after a review of 121 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K130553

510(k) Number K130553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2013
Decision Date July 03, 2013
Days to Decision 121 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
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 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K130553.
DERMISEB CREAM
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K123904 · Mueller Medical International, LLC · Aug 2013
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K131542 · Novabay Pharmaceuticals, Inc. · Jul 2013
PROCELLERA
K130350 · Vomaris Innovations, Inc. · Jul 2013
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING
K123394 · Coreleader Biotech Co., Ltd. · Jun 2013
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
K123481 · Convatec, Inc. · Jun 2013
K130553 · ABSOCLEAR
Download PDF FDA Summary Pharmaplast S.A.E.