Williams Cystoscopic Injection Needle

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

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

• • Ongoing Z-0163-2027 FDA Not yet classified ·initiated 16 Sep 2026

  The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.

Trade Name

Williams

Generic Name

General-purpose endoscopic needle, single-use

Model / Ref / Catalog

090001-S10, 090001-S34, 090001-S26, G15296, G16112, G16684

Primary DI / UDI-DI

00827002152960, 00827002161122, 00827002166844

Basic UDI-DI

B-00827002152960, B-00827002166844, B-00827002161122

510(k) Number

K171602 ↗

FDA Product Code

FBK

EMDN Code

A019099 Needles for other procedures - other

GMDN Term

General-purpose endoscopic needle, single-use

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 876.1500

EU market of registration

Germany

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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• What is the Williams Cystoscopic Injection Needle primarily used for in clinical practice?

  The Williams Cystoscopic Injection Needle is designed for precise injection procedures within the urinary tract, specifically to deliver therapeutic substances like sclerosing agents or gels. It is intended for use during cystoscopic interventions to target areas such as bladder lesions or diverticula, enabling controlled delivery of treatments directly to the affected site.

• Is the Williams Cystoscopic Injection Needle sterile when received, and how should it be prepared for use?

  The Williams Cystoscopic Injection Needle is supplied as a non-sterile instrument and must be sterilized prior to clinical use. It is intended for sterile preparation in accordance with standard aseptic techniques to ensure patient safety before insertion into the urinary tract.

• Can this needle be reused, or is it intended for single-use only?

  The Williams Cystoscopic Injection Needle is explicitly labeled as a single-use device. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.

• What cystoscopic systems is this needle compatible with, and are there any special handling requirements?

  The Williams Cystoscopic Injection Needle is designed to be compatible with standard cystoscopic systems. It must be handled using aseptic techniques to maintain sterility, as it is not pre-sterilized. Proper preparation and adherence to sterile procedures are critical before use.

• What regulatory pathways has this device undergone, and how does it classify under medical device regulations?

  The Williams Cystoscopic Injection Needle has received FDA 510K clearance and complies with the MDD (Medical Device Directive). It is classified as a Class II medical device under FDA regulations (product code FBK, classification 876.1500), indicating it has undergone a traditional 510(k) review process for substantial equivalence.