Cleared Traditional

ELTA ADVANCED WOUND WASH (K073610) - FDA 510(k) Clearance

K073610 · Swiss American Products, Inc. · General & Plastic Surgery device
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Apr 2008
Decision
124d
Days
-
Risk

K073610 is an FDA 510(k) clearance for the ELTA ADVANCED WOUND WASH. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Swiss American Products, Inc. (Carrollton, US). The FDA issued a Cleared decision on April 23, 2008 after a review of 124 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K073610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2007
Decision Date April 23, 2008
Days to Decision 124 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
9d slower than avg
Panel avg: 115d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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