Cleared Abbreviated

K010933 - SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY

K010933 · Alltracel Pharma , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
286d
Days
-
Risk

K010933 is an FDA 510(k) clearance for the SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Alltracel Pharma , Ltd. (Chapel Hill, US). The FDA issued a Cleared decision on January 8, 2002 after a review of 286 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alltracel Pharma , Ltd. devices

FDA 510(k) Submission Details - K010933

510(k) Number K010933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2001
Decision Date January 08, 2002
Days to Decision 286 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 115d · This submission: 286d
Pathway characteristics
Standards-based clearance path.

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 76
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K010933.
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
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TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004
CHITO-SEAL
K021062 · Abbott Vascular, Inc. · Aug 2002
3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214
K982638 · Innovative Technologies , Ltd. · Aug 1998
SORBASTACE
K965034 · Hemostace, LLC · Apr 1998
KALTOSTAT WOUND DRESSING
K910059 · Calgon Vestal Div. · Mar 1991