Cleared Special

K072900 - EXCELARREST FOAM

K072900 · Hemostasis, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
15d
Days
-
Risk

K072900 is an FDA 510(k) clearance for the EXCELARREST FOAM. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on October 26, 2007 after a review of 15 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 Hemostasis, LLC devices

FDA 510(k) Submission Details - K072900

510(k) Number K072900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2007
Decision Date October 26, 2007
Days to Decision 15 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

QSY Device Classification - Class 0,

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 30
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K072900.
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