Cleared Traditional

K103713 - ELTA WOUND CLEANSER

K103713 · Swiss American Products, Inc. · General & Plastic Surgery device
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Jun 2011
Decision
177d
Days
-
Risk

K103713 is an FDA 510(k) clearance for the ELTA WOUND CLEANSER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Swiss American Products, Inc. (Carrollton, US). The FDA issued a Cleared decision on June 16, 2011 after a review of 177 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 Swiss American Products, Inc. devices

FDA 510(k) Submission Details - K103713

510(k) Number K103713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2010
Decision Date June 16, 2011
Days to Decision 177 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 115d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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