Medsurg Percutaneous Transhepatic Cholangiogram

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

510(k) Number

K854297 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESD Substantially Equivalent — Deferred

• Sterile Scrubby Scrub Brush

  Class I

  FDA 510(k) K875033 Active Cleared 19 Feb 1988

• Medsurg Custom Dressing Trays

  Not classified

  FDA 510(k) K861693 Active Cleared 8 Jul 1986

• Medsurg 7 Fr. Dual Lumen Central Vein Cath System

  Class II

  FDA 510(k) K880771 Active Cleared 3 May 1988

• Medsurg Circumcision Tray

  Class II

  FDA 510(k) K920838 Active Cleared 15 Oct 1993

• Medsurg Single Use Basin Set

  Not classified

  FDA 510(k) K861784 Active Cleared 21 May 1986

• Medsurg Epidural Tray/19 Gage Open End Tuohy 1012

  Class II

  FDA 510(k) K890733 Active Cleared 23 Jun 1989

See all devices from Medsurg Industries, Inc. →

• What is the primary purpose of the Medsurg Percutaneous Transhepatic Cholangiogram, and how does it work in a clinical setting?

  The Medsurg Percutaneous Transhepatic Cholangiogram is designed to visualize the biliary tree—including bile ducts, the gallbladder, and pancreatic ducts—using radiographic contrast. It works by inserting a needle percutaneously into the liver, allowing contrast media to be injected so that X-ray imaging can clearly depict the anatomy and any potential obstructions or abnormalities within these structures. This aids in diagnosing conditions like bile duct blockages or gallbladder disease.

• Is this device intended for repeated use, or is it meant to be used only once per procedure?

  This device is explicitly labeled as a single-use tool. After insertion and imaging, it should not be reused, as single-use medical devices are designed for one-time clinical application to ensure patient safety and sterility. Discard it after use according to standard medical waste protocols.

• What storage requirements should be followed for the Medsurg Percutaneous Transhepatic Cholangiogram before use?

  The device must be stored following standard radiographic safety protocols, which typically include keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is single-use and sterile upon packaging, ensure the packaging remains intact until immediately before use to maintain sterility. Avoid exposure to moisture or contamination.

• How was the regulatory approval process for this device structured, and which committee was involved?

  The Medsurg Percutaneous Transhepatic Cholangiogram received FDA 510(k) clearance under the traditional review pathway, filed on October 25, 1985, and approved on November 26, 1985. The review was conducted by the Gastroenterology and Urology (GU) Advisory Committee, reflecting its relevance to both specialties due to its application in biliary and pancreatic duct imaging.