Cleared Traditional

K103067 - EXSALT SD7 WOUND DRESSING

K103067 · Exciton Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
214d
Days
-
Risk

K103067 is an FDA 510(k) clearance for the EXSALT SD7 WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Exciton Technologies, Inc. (Edmonton, CA). The FDA issued a Cleared decision on May 20, 2011 after a review of 214 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.

FDA 510(k) Submission Details - K103067

510(k) Number K103067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2010
Decision Date May 20, 2011
Days to Decision 214 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
99d slower than avg
Panel avg: 115d · This submission: 214d
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 709
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K103067.
CORELEADER ALGIPLASTER MODEL AP 050501
K102942 · Coreleader Biotech Co., Ltd. · Jun 2011
ELTA WOUND CLEANSER
K103713 · Swiss American Products, Inc. · Jun 2011
EMULSION SB
K110732 · Prugen IP Holdings, Inc. · Jun 2011
DURAFIBER AG
K103793 · Smith & Nephew, Inc. · May 2011
CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
K102943 · Coreleader Biotech Co., Ltd. · Apr 2011
PRONTOSAN WOUND IRRIGATION SOLUTION
K110744 · B.Braun Medical, Inc. · Apr 2011
K103067 · EXSALT SD7 WOUND DRESSING
Download PDF FDA Summary Exciton Technologies,…