Product Code: QSX FDA unclassified

Hemostatic Wound Dressing With Thrombin Or Other Biologics

Unknown

The Hemostatic Wound Dressing with Thrombin or Other Biologics is a wound dressing incorporating biologic agents such as thrombin to temporarily control bleeding and cover external wounds by promoting clot formation at the wound site. Its classification is currently unclassified (pending formal classification determination), reviewed under the General and Plastic Surgery panel. Because it contains biologic components that affect classification boundaries, a formal regulatory pathway has not yet been assigned. It is not an implant and not life-sustaining.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code QSX in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: QSX
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

To temporarily control bleeding and cover external wounds.

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K200720	D-Stat Radial Topical Hemostat	Jun 26, 2020	Substantially Equivalent	Vascular Solutions, LLC
K102212	D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER	Apr 08, 2011	Substantially Equivalent	Vascular Solutions, Inc.
K092612	D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505	Sep 11, 2009	Substantially Equivalent	Vascular Solutions, Inc.
K083190	D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015	Nov 12, 2008	Substantially Equivalent	Vascular Solutions, Inc.
K073264	D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005	Dec 07, 2007	Substantially Equivalent	Vascular Solutions, Inc.
K072117	THROMBIX PATCH THROMBIN HEMOSTASIS PATCH	Oct 05, 2007	Substantially Equivalent	Vascular Solutions, Inc.
K070938	THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT	Aug 06, 2007	Substantially Equivalent	Vascular Solutions, Inc.
K063860	THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT	Feb 13, 2007	Substantially Equivalent	Vascular Solutions, Inc.
K061219	D-STAT DRY HEMOSTATIC BANDAGE	Oct 06, 2006	Substantially Equivalent	Vascular Solutions, Inc.
K053644	THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT	Feb 09, 2006	Substantially Equivalent	Vascular Solutions, Inc.
K053054	THROMBIX 3X3 HEMOSTATIC PAD	Nov 23, 2005	Substantially Equivalent	Vascular Solutions, Inc.
K050511	THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT	Apr 14, 2005	Substantially Equivalent	Vascular Solutions, Inc.
K050133	D-STAT RADIAL HEMOSTATIC BAND	Feb 18, 2005	Substantially Equivalent	Vascular Solutions, Inc.
K040510	VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD	Mar 17, 2004	Substantially Equivalent	Vascular Solutions, Inc.
K040118	VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC	Feb 12, 2004	Substantially Equivalent	Vascular Solutions, Inc.
K033709	VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE	Dec 18, 2003	Substantially Equivalent	Vascular Solutions, Inc.
K030836	D-STAT-DRY HEMOSTATIC BANDAGE; D-STAT RADIAL HEMOSTATIC BANDAGE	Sep 17, 2003	Substantially Equivalent	Vascular Solutions, Inc.
K012293	VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT	Jan 18, 2002	Substantially Equivalent	Vascular Solutions, Inc.