Cleared Traditional

K053590 - SILVERLON CA (CALCIUM ALGINATE)

K053590 · Argentum Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
287d
Days
-
Risk

K053590 is an FDA 510(k) clearance for the SILVERLON CA (CALCIUM ALGINATE). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentum Medical, LLC (Conshohocken, US). The FDA issued a Cleared decision on October 6, 2006 after a review of 287 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 Argentum Medical, LLC devices

FDA 510(k) Submission Details - K053590

510(k) Number K053590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2005
Decision Date October 06, 2006
Days to Decision 287 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
172d slower than avg
Panel avg: 115d · This submission: 287d
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 601
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K053590.
MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
K063173 · Advanced Medical Solutions Limited · Nov 2006
SINCLAIR SEBORRHEA EMULSION
K050158 · Sinclair Pharmaceuticals, Ltd. · Oct 2006
MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER
K053538 · Curapharm, Inc. · Oct 2006
ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006
K061232 · Acrymed, Inc. · Oct 2006
ALGICELL AG
K052536 · Derma Sciences Canada, Inc. · Sep 2006
AGCEL WOUND DRESSING,AGCEL BURN DRESSING
K050842 · Modern Medical Equipment Mfg., Ltd. · Aug 2006