Cleared Traditional

K100580 - EXSALT WOUND DRESSING

K100580 · Exciton Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
224d
Days
-
Risk

K100580 is an FDA 510(k) clearance for the EXSALT WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Exciton Technologies, Inc. (Edmonton, CA). The FDA issued a Cleared decision on October 12, 2010 after a review of 224 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 K100580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2010
Decision Date October 12, 2010
Days to Decision 224 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
109d slower than avg
Panel avg: 115d · This submission: 224d
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 K100580.
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
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
K100218 · Coloplast A/S · Feb 2010
MEDLINE CURAD WOUND DRESSINGS
K093349 · Medline Industries, Inc. · Jan 2010
ACTICOAT FLEX 7 DRESSING
K083113 · Smith & Nephew, Inc. · Jul 2009