Cleared Traditional

K083870 - EXSALT SD7 WOUND DRESSING

K083870 · 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
Jul 2009
Decision
213d
Days
-
Risk

K083870 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. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on July 30, 2009 after a review of 213 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 - K083870

510(k) Number K083870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date July 30, 2009
Days to Decision 213 days
Submission Type Traditional
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
98d slower than avg
Panel avg: 115d · This submission: 213d
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 K083870.
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K091013 · Advanced Medical Solutions Limited · Jul 2009
NEOSALUS LOTION
K091719 · Quinnova Pharmaceuticals · Jul 2009
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K083113 · Smith & Nephew, Inc. · Jul 2009
K083870 · EXSALT SD7 WOUND DRESSING
Download PDF FDA Summary Exciton Technologies,…