Wiltek Standard Cholangiography Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K912288 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Wiltek Electrocautery Adaptor

  Class II

  FDA 510(k) K914131 Active Cleared 25 Sep 1991

• Wiltek Biopsy Forceps

  Class II

  FDA 510(k) K930419 Active Cleared 1 Jun 1993

• Wiltek E.R.C.P. Catheter

  Class II

  FDA 510(k) K894867 Active Cleared 21 Dec 1989

• Wiltek Papillotome

  Class II

  FDA 510(k) K894861 Active Cleared 21 Dec 1989

• Wiltek Cytology Brush

  Class II

  FDA 510(k) K894863 Active Cleared 21 Dec 1989

• Wiltek Balloon Stone Extractor

  Class II

  FDA 510(k) K894865 Active Cleared 21 Dec 1989

See all devices from Wiltek Medical, Inc. →

• Is the Wiltek Standard Cholangiography Catheter designed for reuse in clinical settings, or is it intended for single-use only?

  The Wiltek Standard Cholangiography Catheter is explicitly designed for single-use in clinical settings like endoscopy or fluoroscopy. It is supplied sterile and packaged for one-time use only, as stated in the device description.

• What types of procedures is this catheter primarily used for, and how does it assist in diagnosis?

  This catheter is intended for diagnostic and therapeutic procedures within the biliary system, such as cholangiography. It facilitates visualization of the bile ducts by allowing contrast injection, which helps identify obstructions, strictures, or other pathologies during procedures like ERCP (endoscopic retrograde cholangiopancreatography).

• How is the catheter packaged and stored, and what should clinicians consider before use?

  The catheter is supplied sterile and pre-packaged for single-use, meaning it does not require additional sterilization before use. Clinicians should ensure the packaging remains intact and unopened before use, as it is not designed for reuse or reprocessing. Storage conditions are not specified, but standard sterile medical device storage practices should be followed.

• What regulatory pathway was followed for FDA clearance of this catheter, and what does that mean for its use?

  The Wiltek Standard Cholangiography Catheter received FDA 510(k) clearance (K912288) under regulation number 876.5010, which means it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates it meets FDA safety and effectiveness standards for its intended use in biliary duct procedures, but it does not imply any specific clinical indication beyond what is described in the device data.