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Hemospray Endoscopic Hemostat HEMO-10

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref HEMO-10510(k) K200972

by Wilson-Cook Medical, Inc.

Identity

Trade Name
Hemospray Endoscopic Hemostat EUDAMED
Hemospray® Endoscopic Hemostat EUDAMED
Hemospray FDA UDI
Generic Name
Non-organic haemostatic agent FDA UDI
Device Name
Hemospray Endoscopic Hemostat EUDAMEDFDA UDI
Model / Reference
HEMO-10 EUDAMED
G21049 FDA UDI
Description
HEMOSPRAY ENDOSCOPIC HEMOSTAT FDA UDI

Identifiers

Catalog Number
HEMO-10 FDA UDI
Primary DI / UDI-DI
00827002210493 EUDAMEDFDA UDI
Basic UDI-DI
0827002WCM00000000017MR EUDAMED
FDA Product Code
QAU FDA UDI
EMDN Code
G020499 GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER EUDAMED
GMDN Term
Non-organic haemostatic agent FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4456 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Hemospray Endoscopic Hemostat HEMO-10 is a hemostatic device for endoscopic gastrointestinal use, classified under nomenclature code G020499. It is designed to achieve hemostasis by delivering a sprayable, adhesive polymer that forms a seal over bleeding sites within the gastrointestinal tract, effectively stopping nonvariceal bleeding during endoscopic procedures.

This device is supplied sterile and is intended for single-use only. It is non-implantable and non-reusable, with no active components beyond its spray mechanism. The Hemospray Endoscopic Hemostat HEMO-10 is regulated under FDA 510K and MDR authorizations, adhering to Class IIb standards. It is packaged for use in clinical settings where endoscopic procedures are performed, ensuring compatibility with standard endoscopic equipment.

Frequently asked questions

What is the Hemospray HEMO-10 Endoscopic Hemostat used for?

The Hemospray HEMO-10 is designed specifically for achieving hemostasis in the gastrointestinal tract during endoscopic procedures. It works by delivering a sprayable, adhesive polymer that forms a seal over bleeding sites, effectively stopping nonvariceal bleeding. This makes it ideal for clinical settings where endoscopic interventions are performed to control gastrointestinal hemorrhage.

How is the Hemospray HEMO-10 supplied and what are its sterility and usage guidelines?

The Hemospray HEMO-10 is supplied sterile and is intended for single-use only. It is non-implantable and non-reusable, meaning each device is meant to be used once and then discarded. The sterile packaging ensures it is ready for immediate clinical use without additional preparation, adhering to standard endoscopic procedure protocols.

Is the Hemospray HEMO-10 compatible with existing endoscopic equipment?

Yes, the Hemospray HEMO-10 is designed to be compatible with standard endoscopic equipment. Its spray mechanism and delivery system are engineered to integrate seamlessly with existing gastrointestinal endoscopy tools, ensuring ease of use during procedures without requiring additional modifications or accessories.

What regulatory authorizations does the Hemospray HEMO-10 hold?

The Hemospray HEMO-10 is authorized under FDA 510K clearance and MDR (Medical Device Regulation) standards. It falls under Class IIb classification, indicating it has been evaluated for safety and effectiveness through regulatory pathways that ensure compliance with stringent medical device requirements.

Does the Hemospray HEMO-10 contain any active components beyond its spray mechanism?

No, the Hemospray HEMO-10 contains no active components beyond its spray mechanism. It relies solely on the adhesive polymer delivery system to achieve hemostasis, making it a passive device for sealing bleeding sites without electrical, mechanical, or pharmacological activation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hemospray® Endoscopic Hemostat - Cook Medical, Hemospray® Endoscopic Hemostat - Cook Medical, COOK Medical Hemospray Endoscopic Hemostat Instructions Manual, COOK MEDICAL HEMOSPRAY SERIES MANUAL Pdf Download

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Wilson-Cook Medical, Inc.
EUDAMED SRN
US-MF-000002658
Authorised Representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Sources (4)

  • EUDAMED 0b4cbaff-2d8a-4f00-8658-320af46e6c25 85 fields · synced Oct 6, 2026
  • FDA UDI 442ff61c-2459-4cf7-a237-0b3f93b71aed 36 fields · synced May 29, 2026
  • EUDAMED 35ca88ba-dba6-452a-875b-8e9fa6f088bd 61 fields · synced Jun 20, 2026
  • FDA 510(k) DEN170015 1 fields · synced May 18, 2026