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

• • Terminated Z-2706-2017 FDA Class II ·initiated 17 Feb 2017

  Fujifilm is recalling multiple endoscopes after a retrospective review.

510(k) Number

K063847 ↗

FDA Product Code

FDS

Models / Variants

Eg-530UR

Eg-530UT

Su-700

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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

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  FDA 510(k) K120446 Active Cleared 13 Aug 2012

• Laparoscopic Lymphadenectomy

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  FDA 510(k) K930817 Active Cleared 28 Jul 1993

• Fujinon Ultrasonic Processor

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  FDA 510(k) K111243 Active Cleared 16 May 2011

• Fujinon Video Laparoscope -- Modified

  Class II

  FDA 510(k) K932312 Active Cleared 16 Feb 1994

• Fujinon Video Laparoscope--Thoracoscopy

  Class II

  FDA 510(k) K931223 Active Cleared 28 Jul 1993

See all devices from Fujinon, Inc. →

• What clinical specialties is this ultrasonic endoscope system primarily used in, and how does it combine imaging modalities to aid diagnosis?

  The Fujinon Ultrasonic Endoscope and Processor system (models EG-530UR, EG-530UT, and SU-700) is primarily used in gastroenterology and urology, as indicated by its advisory committee classification. It combines real-time ultrasound imaging with endoscopic visualization to provide detailed visualization of the upper digestive tract (esophagus, stomach, duodenum) and surrounding submucosal or peripheral organs. This dual-modality approach helps clinicians assess anatomical structures and pathologies more comprehensively than traditional endoscopy alone.

• Are the ultrasonic endoscopes (EG-530UR/EG-530UT) single-use or reusable, and what sterilization or cleaning requirements apply?

  The ultrasonic endoscopes (models EG-530UR and EG-530UT) are reusable devices, as stated in the device description. They must be cleaned, disinfected, or sterilized according to manufacturer guidelines to ensure safety and functionality. The data does not specify sterilization methods, so adherence to Fujinon’s protocols is critical to maintain device integrity and prevent cross-contamination.

• How is the system supplied, and can the endoscopes be obtained in sterile or non-sterile configurations?

  The system is supplied with reusable ultrasonic endoscopes (EG-530UR/EG-530UT) paired with the SU-700 processor. The endoscopes can be obtained in either sterile or non-sterile configurations depending on procedural requirements, as noted in the description. Sterility is not a fixed attribute but rather a customizable option to align with clinical workflows (e.g., sterile for minimally invasive procedures, non-sterile for routine cleaning/reuse).

• What regulatory pathway was followed for FDA clearance of this device, and what does the ‘GU’ advisory committee designation indicate?

  The Fujinon Ultrasonic Endoscope and Processor received FDA clearance via a 510(k) submission (K063847), classified as substantially equivalent under the traditional review pathway. The ‘GU’ advisory committee designation refers to the Gastroenterology and Urology (GU) Panel, which reviewed the submission to ensure the device met safety and effectiveness standards for its intended use in these specialties. This panel evaluates devices like gastroscopes and accessories, aligning with the system’s primary applications.