Injekt Filiform Injection Needle

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K082319 ↗

FDA Product Code

FBK

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 3 Way Silicone Foley Balloon Catheter

  Class II

  FDA 510(k) K091767 Active Cleared 9 Oct 2009

• Aq Hydrophilic Dilators

  Class II

  FDA 510(k) K961904 Active Cleared 18 Oct 1996

• Bipolar Cutter

  Class II

  FDA 510(k) K955618 Active Cleared 22 Jan 1996

• Rutner Biopsy Device

  Class II

  FDA 510(k) K950810 Active Cleared 6 Mar 1995

• CO2 Pneumo-Dissector

  Class II

  FDA 510(k) K972647 Active Cleared 10 Apr 1998

• Pgd-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)

  Class II

  FDA 510(k) K014160 Active Cleared 8 Feb 2002

See all devices from Cook Urological, Inc. →

• What is the INJEKT FILIFORM INJECTION NEEDLE used for?

  The INJEKT FILIFORM INJECTION NEEDLE is designed for the precise delivery of therapeutic agents into the genitourinary system during urological and gastrointestinal endoscopic procedures, enabling targeted treatment in clinical settings.

• How is the INJEKT FILIFORM INJECTION NEEDLE supplied and is it reusable?

  The device is supplied sterile and intended for single-use only, meaning it must be discarded after one procedure to prevent cross-contamination and ensure patient safety, as reuse could compromise sterility and functionality.

• What regulatory clearance does the INJEKT FILIFORM INJECTION NEEDLE have?

  The INJEKT FILIFORM INJECTION NEEDLE has received FDA 510(k) clearance under K082319 with product code FBK and is classified as a Class II medical device under regulation 876.1500, indicating it was found substantially equivalent to a legally marketed predicate device.