Cleared Special

K113564 - EXSALT T7 WOUND DRESSING

K113564 · Exciton Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
13d
Days
-
Risk

K113564 is an FDA 510(k) clearance for the EXSALT T7 WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Exciton Technologies, Inc. (Edmonton, Alberta, CA). The FDA issued a Cleared decision on December 15, 2011 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Exciton Technologies, Inc. devices

FDA 510(k) Submission Details - K113564

510(k) Number K113564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2011
Decision Date December 15, 2011
Days to Decision 13 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 457
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K113564.
DEXERYL CREAM
K113807 · Pierre Fabre Medical Devices · Mar 2012
HPR EMOLLIENT FOAM
K113772 · Prugen IP Holdings, Inc. · Feb 2012
HPR PLUS EMOLLIENT FOAM
K113774 · Prugen IP Holdings, Inc. · Feb 2012
PRECISION SKIN EMULSION
K111168 · Precision Dermatology Incorporated · Dec 2011
3M TEGADERM MATRIX DRESSING
K110457 · 3M Company · Dec 2011
AVO BARRIER TOPICAL EMULSION
K110762 · Trigen Laboratories, Inc. · Nov 2011