Cleared Special

K122886 - NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL H...

K122886 · Hemostasis, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
56d
Days
-
Risk

K122886 is an FDA 510(k) clearance for the NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING. 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 November 15, 2012 after a review of 56 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 - K122886

510(k) Number K122886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2012
Decision Date November 15, 2012
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 K122886.
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CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
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