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HEMOSTATIX MEDICAL TECHNOLOGIES LLC

Last updated May 27, 2026

What HEMOSTATIX MEDICAL TECHNOLOGIES LLC makes

The company manufactures haemostatic knives designed for surgical procedures, including a thermal scalpel system with interchangeable blades, handles, and a controller unit. These devices are intended to cut tissue while simultaneously sealing blood vessels to minimise bleeding during operations.

The portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) and UDI requirements. These products are listed in the FDA’s regulatory databases, and the company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: hemostatix.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(901)261-0012
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 791221265

Catalogue (18)

Device	Model / Reference	Registries	Class	Status
Hemostatix Thermal Scalpel System Model P8400 Controller	7013-8400	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 9050 Handle	7013-9050	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Handle	7023-5815	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 5715 Blade - Qty 24	7013-5715	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 5812 Blade	7023-5812	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 5715 Blade - Qty 10	7023-5715	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model P8400 Footswitch	7013-8410	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Blade	7013-5815	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 8051 Handle - Qty 1	7013-8051	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 5810 Blade	7023-5810	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 5712 Blade - Qty 10	7023-5712	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 9050 Handle	7023-9050	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 5710 Blade - Qty 10	7023-5710	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 5710 Blade - Qty 24	7013-5710	FDA UDI	Class II	Active
HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5810 Blade	7013-5810	FDA UDI	Class II	Active
Hemostatix Thermal Scalpel System Model 8050 Handle - Qty 1	7013-8050	FDA UDI	Class II	Active
Model P8400 Hemostatix Thermal Scalpel System	K091107	FDA 510(k)	Class II	Active
Hemostatix Model P8400 Disposable Handle, Hemostatix Model P8400 Disposable Blades	K183009	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Hemostatix Medical Technologies LLC has two recall records, both initiated on July 27, 2010. Both recalls are listed with a terminated status. The reasons provided for the recalls state a lack of sterility assurance.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jul 27, 2010	Z-2595-2010	—	terminated	Lack of sterility assurance
Jul 27, 2010	Z-2596-2010	—	terminated	Lack of sterility assurance