Cleared Traditional

K053538 - MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER

K053538 · Curapharm, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
294d
Days
-
Risk

K053538 is an FDA 510(k) clearance for the MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Curapharm, Inc. (Santee, US). The FDA issued a Cleared decision on October 10, 2006 after a review of 294 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 - K053538

510(k) Number K053538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2005
Decision Date October 10, 2006
Days to Decision 294 days
Submission Type Traditional
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
179d slower than avg
Panel avg: 115d · This submission: 294d
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 708
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K053538.
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S
K062212 · Anacapa Technologies, Inc. · Nov 2006
MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
K063173 · Advanced Medical Solutions Limited · Nov 2006
SINCLAIR SEBORRHEA EMULSION
K050158 · Sinclair Pharmaceuticals, Ltd. · Oct 2006
SILVERLON CA (CALCIUM ALGINATE)
K053590 · Argentum Medical, LLC · Oct 2006
ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006
K061232 · Acrymed, Inc. · Oct 2006
ALGICELL AG
K052536 · Derma Sciences Canada, Inc. · Sep 2006
K053538 · MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER
Download PDF FDA Summary Curapharm, Inc.