Laparoscopic Cholangiography Catheter

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

510(k) Number

K922190 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SEKD

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See all devices from Advanced Surgical, Inc. →

• What is the Laparoscopic Cholangiography Catheter used for?

  It is used to image the biliary tract during laparoscopic procedures, specifically to visualize the common bile duct and associated structures, aiding in intraoperative assessment of bile duct anatomy and pathology.

• Is the Laparoscopic Cholangiography Catheter sterile or non-sterile, and is it reusable?

  The device is supplied non-sterile and is intended for single use only; it must be sterilized by the user before each procedure and discarded afterward to prevent cross-contamination and ensure patient safety.

• What regulatory clearance does the Laparoscopic Cholangiography Catheter have, and when was it granted?

  It received FDA 510(k) clearance under submission K922190 on October 23, 1992, and is classified under product code FMF for use in general hospital settings, indicating substantial equivalence to a legally marketed predicate device.