Hemoblock_S (Prescription); Hemoblock_S (OTC)

Q: What is the product code of K232216?

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

FDA 510(k) K232216 · Incore Co., Ltd.

Substantially Equivalent

510(k) numberK232216

Submission

Device name: Hemoblock_S (Prescription); Hemoblock_S (OTC)
Applicant: Incore Co., Ltd.
Daegu, KR
Received: July 26, 2023
Decision date: April 19, 2024
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
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
K213413	Hemostatic DressingQSY · Traditional	Jiangsu Newvalue Medical Products Co., Ltd.	09/01/2023SE

More from Jiangsu Newvalue Medical Products Co., Ltd.

510(k)	Device	Decision
K221054	Core-InjectorFBK · Traditional	12/21/2022SE
K220846	Core-SnareFDI · Traditional	11/21/2022SE
K220081	Core-SportOTJ · Traditional	09/28/2022SE
K213338	Core-ClipPKL · Traditional	06/23/2022SE
K211148	CORE-TrocarGCJ · Traditional	06/21/2022SE

Questions and answers

When was Hemoblock_S (Prescription); Hemoblock_S (OTC) cleared by the FDA?

Hemoblock_S (Prescription); Hemoblock_S (OTC) (K232216) received a 510(k) decision of Substantially Equivalent on April 19, 2024, 268 days after the submission was received.

What is the product code of K232216?

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