Axiostat Chitosan Hemostatic Dressing

Q: What is the product code of K172324?

The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.

FDA 510(k) K172324 · Advamedica, Inc.

Substantially Equivalent

510(k) numberK172324

Submission

Device name: Axiostat Chitosan Hemostatic Dressing
Applicant: Advamedica, Inc.
Cambridge, MA, US
Received: August 1, 2017
Decision date: February 23, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device class: Unclassified

To temporarily control bleeding and cover external wounds.

Other 510(k)s with product code QSY

510(k)	Device	Applicant	Decision
K253017	BloodSTOP iX Trauma Matrix (TM-iX-20)QSY · Traditional	Lifescience Plus, Inc.	04/30/2026SE
K251700	Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…QSY · Traditional	Speciality Fibres and Materials Limited	02/26/2026SE
K250319	Mfuse (MS001)QSY · Traditional	Machina Medical, Inc.	12/15/2025SE
K253609	TRAUMAGEL® 2.0 Hemostatic GelQSY · Special	Cresilon, Inc.	12/12/2025SE
K240713	Traumagel®QSY · Traditional	Cresilon, Inc.	08/14/2024SE
K240097	Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)QSY · Traditional	Ushare Medical, Inc.	05/22/2024SE
K232216	Hemoblock_S (Prescription); Hemoblock_S (OTC)QSY · Traditional	Incore Co., Ltd.	04/19/2024SE
K240454	RESPONDER® Polysaccharide HemostatQSY · Special	Starch Medical, Inc.	03/15/2024SE
K220525	RESPONDER Polysaccharide HemostatQSY · Traditional	Starch Medical, Inc.	12/04/2023SE
K230589	Celox Rapid X-Ray GauzeQSY · Traditional	Medtrade Products , Ltd.	11/17/2023SE

More from Medtrade Products , Ltd.

510(k)	Device	Decision
K212766	Maxiocel Chitosan Wound DressingKGN · Traditional	08/24/2023SE
K222909	Axiostat GauzeQSY · Traditional	04/07/2023SE
K213198	Ax-Surgi Surgical HemostatPOD · Traditional	01/05/2023SE
K202830	Axiostat PatchQSY · Traditional	04/15/2021SE

Questions and answers

When was Axiostat Chitosan Hemostatic Dressing cleared by the FDA?

Axiostat Chitosan Hemostatic Dressing (K172324) received a 510(k) decision of Substantially Equivalent on February 23, 2018, 206 days after the submission was received.

What is the product code of K172324?

The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.