Cleared Abbreviated

SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY (K010933) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

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