Cleared Traditional

ELTA WOUND CLEANSER (K103713) - FDA 510(k) Clearance

K103713 · Swiss American Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 701
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K103713.
StatSeal Disc
K254073 · Merit Medical Systems, Inc. · May 2026
IWD-Gel™
K254191 · InnovaCorium, Inc. · Apr 2026
MiraChlor Antimicrobial Wound Solution
K252023 · Letus Corporation · Mar 2026
Promogran Prisma™ Collagen Matrix with ORC and Silver
K251999 · Solventum Germany GmbH · Mar 2026
LUOFUCON® Antimicrobial Wound Gel
K252028 · Huizhou Foryou Medical Co., Ltd. · Mar 2026
Redermax Antibacterial Wound Matrix
K251582 · Beijing Kreate Medical Co., Ltd. · Feb 2026