Kahook Dual Blade Glide (KDB Glide)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

Kdb Glide EUDAMED

Kahook Dual Blade Glide GUDID

Generic Name

Ophthalmic knife, single-use

Model / Ref / Catalog

KDB Glide, 10-0065

Primary DI / UDI-DI

00892064002003

Basic UDI-DI

B-00892064002003

510(k) Number

K220891 ↗

FDA Product Code

QUQ, HNN

EMDN Code

Q021199 Ophthalmic surgery instruments, single-use - other

GMDN Term

Ophthalmic knife, single-use

Device Class

Class IIa EUDAMED

Class II 510(k)

Class I GUDID

Regulation

21 CFR Part 878.4400 510(k)GUDID

886.4350 GUDID

EU market of registration

Netherlands

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Manufacturer's product page: KDB GLIDE®

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• What is the Kahook Dual Blade Glide (KDB Glide) used for in clinical practice?

  The KDB Glide is specifically designed for trabecular bypass surgery, a minimally invasive procedure aimed at reducing intraocular pressure in patients with glaucoma. It works by creating a pathway to improve the outflow of aqueous humor through the trabecular meshwork, helping to manage elevated eye pressure.

• Is the KDB Glide intended for single-use or repeated use, and how should it be handled?

  The KDB Glide is a single-use, sterile surgical instrument. Due to its disposable nature, it must be handled using standard aseptic techniques to ensure sterility and prevent contamination during ophthalmic procedures.

• What storage instructions should be followed to maintain the device’s sterility and functionality?

  The device should be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is sterile upon packaging, it must remain unopened until use and protected from environmental contamination.

• What regulatory pathways has the KDB Glide undergone, and where is it authorized for use?

  The KDB Glide has received FDA 510(k) clearance under the reference number K220891, confirming it is substantially equivalent to a legally marketed predicate device. It is also compliant with the Medical Device Directive (MDD) and is classified as a Class II device, authorizing its use in the United States and within the European Economic Area under applicable regulations.