Endoscopy Kit - Basic Aux HB DKT1HA0008A

• FDA 510(k) K220210 decided 17 Jun 2022 Active
• FDA GUDID UDI-DI 00850025860970 listed 12 Oct 2026 Listed

1. 17 Jun 2022 Cleared FDA 510(k) K220210
2. 12 Oct 2026 Listed FDA GUDID 00850025860970

Trade name

Endoscopy Kit - Basic Aux HB

Generic name

Endoscopy preparation kit

Model / reference

DKT1HA0008A

Description

Endoscopy Kit, Basic HB, Sterile Lube 1.25oz, Woven Gauze x 10, Basin, Enzymatic Sponge, Pad and BioHazard Label, Aux Water Connector Oly, Single Use

Primary DI / UDI-DI

00850025860970

510(k) Number

K220210 ↗

FDA product code

KMJ, MNL, ODC

GMDN term

Endoscopy preparation kit

Device class

Class I

Regulation number

880.6375, 876.1500

GUDID distribution status

In Commercial Distribution

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