Catheter Cholangiography

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

510(k) Number

K921921 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Electrosurgical Cutting/Coagulation Device/Access

  Class II

  FDA 510(k) K914066 Active Cleared 7 Nov 1991

• Laparomed Cholangiogram Vacuum Device

  Class II

  FDA 510(k) K910218 Active Cleared 8 Apr 1991

• Laparomed Hook/Spatula Device

  Class II

  FDA 510(k) K910074 Active Cleared 2 Jul 1991

• Laparomed Laparoscopic Retractor System

  Class II

  FDA 510(k) K930569 Active Cleared 20 Apr 1993

• Laparoscopic Retractor System

  Class II

  FDA 510(k) K921006 Active Cleared 28 Jul 1992

• Suture Applier Device

  Class II

  FDA 510(k) K905722 Active Cleared 14 Mar 1991

See all devices from Laparomed Corp. →

• What is the catheter cholangiography used for?

  The catheter cholangiography is used for imaging the biliary system, specifically to visualize the bile ducts during medical procedures, as stated in the device description.

• Who manufactures the catheter cholangiography device?

  The catheter cholangiography device is manufactured by Laparomed Corp., as indicated in the manufacturer field of the device data.

• What regulatory clearance does the catheter cholangiography have?

  The device received FDA 510(k) clearance under K921921 on August 17, 1992, and is classified under product code GEI, as specified in the authorizations and specifications sections.

• Is the catheter cholangiography substantially equivalent to a predicate device?

  Yes, the device was found to be substantially equivalent to a predicate device, as indicated by the decision_code 'SESE' and decision_description 'Substantially Equivalent' in the specifications.