Cleared Traditional

K103067 - EXSALT SD7 WOUND DRESSING

K103067 · Exciton Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Exciton Technologies, Inc. devices

Submission Details

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.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 212
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K103067.
CURAD ANTIBACTERIAL BANDAGE
K113583 · Medline Industries, Inc. · Apr 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
K120828 · Coloplast A/S · Apr 2012
3M TEGADERM MATRIX DRESSING
K110457 · 3M Company · Dec 2011
DURAFIBER AG
K103793 · Smith & Nephew, Inc. · May 2011
PRONTOSAN WOUND IRRIGATION SOLUTION
K110744 · B.Braun Medical, Inc. · Apr 2011
PRONTOSAN ANTIMICROBIAL WOUND GEL
K101882 · B.Braun Medical, Inc. · Nov 2010