Cleared Traditional

K141863 - PURICORE WOUND HYDROGEL SPRAY DRESSING

K141863 · Puricore, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
308d
Days
-
Risk

K141863 is an FDA 510(k) clearance for the PURICORE WOUND HYDROGEL SPRAY DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Puricore, Inc. (Malvern, US). The FDA issued a Cleared decision on May 14, 2015 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Puricore, Inc. devices

FDA 510(k) Submission Details - K141863

510(k) Number K141863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2014
Decision Date May 14, 2015
Days to Decision 308 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
193d slower than avg
Panel avg: 115d · This submission: 308d
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 261
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K141863.
DURAFIBER Ag
K161289 · Smith & Nephew Medical Limited · Aug 2016
Medihoney Wound Gel
K150985 · Derma Sciences, Inc. · Nov 2015
MEDIHONEY WOUND DRESSINGS
K133279 · Derma Sciences, Inc. · Jun 2015
LUOFUCON SILVER FOAM DRESSING
K141619 · Huizhou Foryou Medical Devices Co., Ltd. · Apr 2015
LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING
K140954 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2015
PRONTOSAN WOUND GEL X
K130857 · B.Braun Medical, Inc. · Oct 2013