Cleared Traditional

K033291 - TOPSEAL HEMOSTATIC DRESSING, MODEL 11150

K033291 · Radi Medical Systems AB · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
155d
Days
-
Risk

K033291 is an FDA 510(k) clearance for the TOPSEAL HEMOSTATIC DRESSING, MODEL 11150. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on March 17, 2004 after a review of 155 days - an extended review cycle.

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 Radi Medical Systems AB devices

FDA 510(k) Submission Details - K033291

510(k) Number K033291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date March 17, 2004
Days to Decision 155 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 115d · This submission: 155d
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 117
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K033291.
QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
K051955 · Z-Medica Corporation · Aug 2005
HEMCON BANDAGE AND HEMCON BANDAGE OTC
K043050 · Hemcon, Inc. · Jun 2005
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
K050769 · Z-Medica Corporation · Apr 2005
CHITO-SEAL
K021062 · Abbott Vascular, Inc. · Aug 2002
HEMOSORB
K021581 · On Site Gas Systems, Inc. · Jul 2002
HEMADERM COTAINING HEMADEX CLOTTING BEADS
K021678 · Medafor, Inc. · Jul 2002