Cleared Traditional

K053538 - MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER

K053538 · Curapharm, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Curapharm, Inc. devices

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
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 320
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