Fujinon G5 Duodenoscopes ED-450XT5, ED-250XT5

• 3 recalls, same reason

  • Terminated Z-1864-2016 FDA Class II ·initiated 23 Dec 2015
  • Terminated Z-1863-2016 FDA Class II ·initiated 23 Dec 2015
  • Terminated Z-1860-2016 FDA Class II ·initiated 23 Dec 2015

  This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

• • Terminated Z-2778-2015 FDA Class II ·initiated 30 Jun 2015

  The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.

Full name

Fujinon G5 Duodenscopes; G5 Duodenoscopes, Ed-450XT5, Ed-250XT5

510(k) Number

K042076 ↗

FDA Product Code

FDT

Models / Variants

Fujinon G5 Duodenscopes

G5 Duodenoscopes, Ed-450XT5, Ed-250XT5

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT, and SU-700

  Class II

  FDA 510(k) K063847 Active Cleared 1 Mar 2007

• Fujinon Double Balloon Enteroscopy System

  Class II

  FDA 510(k) K040048 Active Cleared 7 Jun 2004

• Fujinon/Fujifilm Ultrasonic Endoscope Eg-530UR2 and Eg-530UT2

  Class II

  FDA 510(k) K120446 Active Cleared 13 Aug 2012

• Laparoscopic Lymphadenectomy

  Class II

  FDA 510(k) K930817 Active Cleared 28 Jul 1993

• Fujinon Ultrasonic Processor

  Class II

  FDA 510(k) K111243 Active Cleared 16 May 2011

• Fujinon Video Laparoscope -- Modified

  Class II

  FDA 510(k) K932312 Active Cleared 16 Feb 1994

See all devices from Fujinon, Inc. →

• What are the Fujinon G5 Duodenoscopes (ED-450XT5, ED-250XT5) used for?

  The Fujinon G5 Duodenoscopes are designed for visualization and diagnostic procedures of the upper digestive tract, including the duodenum. The ED-450XT5 features a large working channel, making it suitable for therapeutic interventions alongside diagnostic imaging, while the ED-250XT5 offers a 100-degree field of view for enhanced precision during examinations. These devices are commonly used in gastroenterology and urology for both diagnostic and therapeutic purposes.

• Are the Fujinon G5 Duodenoscopes single-use or reusable?

  The Fujinon G5 Duodenoscopes are reusable medical devices. To maintain safety and functionality, they require proper cleaning, disinfection, and sterilization following manufacturer guidelines. Reuse is only permissible when these protocols are strictly adhered to, ensuring the device remains sterile and operational for subsequent procedures.

• What distinguishes the ED-450XT5 from the ED-250XT5 in terms of functionality?

  The primary distinction lies in their design features: the ED-450XT5 is equipped with a large working channel, which allows for easier insertion of therapeutic instruments during procedures. In contrast, the ED-250XT5 provides a 100-degree field of view, offering enhanced precision and a broader perspective during diagnostic examinations. Both models incorporate distal CCD sensors for high-resolution imaging.

• How should these duodenoscopes be stored to maintain performance and sterility?

  Storage and handling of the Fujinon G5 Duodenoscopes must follow the manufacturer’s guidelines to preserve performance and sterility. After cleaning, disinfection, and sterilization, they should be stored in a clean, dry environment, protected from physical damage and contamination. The devices should be kept in their original packaging or a designated storage case to prevent exposure to dust, moisture, or other contaminants that could compromise their integrity.

• What regulatory compliance does the Fujinon G5 Duodenoscope hold?

  The Fujinon G5 Duodenoscopes (ED-450XT5, ED-250XT5) are classified under FDA regulation 876.1500 and hold a 510(k) clearance, indicating they are deemed substantially equivalent to a legally marketed predicate device. This clearance ensures compliance with U.S. regulatory standards for flexible/rigid duodenoscopes, confirming their safety and effectiveness for intended clinical use.