Cleared Traditional

K102459 - NEXSTAT (TM) TOPICAL HEMOSTAT POWDER

Also marketed or referenced as:
NEXFOAM (R) TOPICAL SPONGE
K102459 · Hemostasis, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
98d
Days
-
Risk

K102459 is an FDA 510(k) clearance for the NEXSTAT (TM) TOPICAL HEMOSTAT POWDER. 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 December 3, 2010 after a review of 98 days - within the typical 510(k) review window.

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 Hemostasis, LLC devices

FDA 510(k) Submission Details - K102459

510(k) Number K102459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2010
Decision Date December 03, 2010
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

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 K102459.
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