Eg-3630UR, Ultrasund Video Gastroscope

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

510(k) Number

K013640 ↗

FDA Product Code

FDS

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Pentax Precision Instrument Corp. →

• What is the EG-3630UR Ultrasound Video Gastroscope used for?

  The EG-3630UR Ultrasound Video Gastroscope is designed for optical and ultrasonic visualization of the upper gastrointestinal tract. It provides simultaneous anatomical and functional assessment of the esophagus, stomach, duodenum, small bowel, and surrounding tissues. This dual-modality approach helps clinicians evaluate both structural and functional characteristics during procedures.

• How is the EG-3630UR supplied and what accessories are required?

  The EG-3630UR is supplied as a reusable medical instrument and includes a flexible insertion tube, control body, PVE umbilical connector, and scanner umbilical connector. To operate this device, it must be connected to a Pentax Video Processor and an Ultrasound Scanner, as these components are essential for imaging and ultrasound functionality.

• Is the EG-3630UR single-use or reusable?

  The EG-3630UR Ultrasound Video Gastroscope is classified as a reusable medical device. Reusability is typical for endoscopes to reduce waste and cost, but it requires strict adherence to cleaning, disinfection, and sterilization protocols to ensure patient safety and device longevity.

• What regulatory pathway does the EG-3630UR follow?

  The EG-3630UR Ultrasound Video Gastroscope has received FDA 510(k) clearance, indicating it is deemed substantially equivalent to a legally marketed predicate device. It is classified under FDA regulation 876.1500 as a Class II medical device, which requires premarket notification to the FDA before marketing.

• What are the primary clinical applications for this device?

  The EG-3630UR is primarily used in gastroenterology and urology for procedures requiring detailed visualization of the upper gastrointestinal tract. Its ultrasound capabilities allow for enhanced assessment of tissue characteristics, such as identifying lesions, evaluating vascular structures, or diagnosing abnormalities in the esophagus, stomach, duodenum, and surrounding areas. This dual-modality approach supports comprehensive diagnostic evaluations.