Cleared Traditional

K131796 - MANUKA FILL WOUND DRESSING

K131796 · Links Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
269d
Days
-
Risk

K131796 is an FDA 510(k) clearance for the MANUKA FILL WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Links Medical Products, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on March 14, 2014 after a review of 269 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.

FDA 510(k) Submission Details - K131796

510(k) Number K131796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2013
Decision Date March 14, 2014
Days to Decision 269 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
154d slower than avg
Panel avg: 115d · This submission: 269d
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 K131796.
BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE
K140147 · Bio-Medical Carbon Technology Co., Ltd. · Apr 2014
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
K131848 · Puricore, Inc. · Mar 2014
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
K133775 · Exciton Technologies, Inc. · Mar 2014
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL
K133764 · Avery Dennison Belgie Bvba · Mar 2014
IPM WOUND GEL BIO
K123193 · Glycobiosciences, Inc. · Mar 2014
L.A.M. IPM WOUND GEL, IPM DERM GEL
K130781 · Glycobiosciences, Inc. · Feb 2014
K131796 · MANUKA FILL WOUND DRESSING
Download PDF FDA Summary Links Medical Product…