Olympus XGIF-N200H Gastrointestinal Videoscope

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

510(k) Number

K001766 ↗

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 Olympus Optical Co., Ltd. →

• Is the Olympus XGIF-N200H gastroscope designed for single-use or reusable procedures, and what maintenance is required?

  The Olympus XGIF-N200H is a reusable flexible gastroscope intended for repeated use in controlled clinical settings like hospitals and endoscopy units. Since it is reusable, it must undergo rigorous cleaning, disinfection, and sterilization between procedures to ensure safety and functionality. This aligns with FDA regulations for reusable endoscopes, which emphasize proper reprocessing protocols to prevent cross-contamination and maintain device integrity.

• What types of clinical settings or specialties is this device primarily intended for, based on its regulatory classification?

  The Olympus XGIF-N200H is primarily intended for use in gastroenterology, as indicated by its FDA classification under device class 2 and its registration in the Gastroenterology specialty category. While the advisory committee listing also includes Urology, the device’s description explicitly states it is designed for visual examination of the upper gastrointestinal tract (esophagus, stomach, and duodenum), making gastroenterology its core clinical application.

• How is the regulatory approval status of this device described, and what does that mean for purchasing or clinical use?

  The Olympus XGIF-N200H holds an FDA 510(k) clearance (K001766), which means it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms the device meets FDA safety and effectiveness requirements for its intended use as a flexible gastroscope. For purchasing or clinical use, this indicates compliance with U.S. regulatory standards, though end-users must still follow manufacturer reprocessing guidelines and institutional protocols for safe operation.

• Does this device have any specific MRI safety considerations, and why might that matter for clinical workflows?

  While the provided data does not explicitly state MRI compatibility, the mention of MRI safety considerations in the reprocessing requirements implies the device may need to be handled carefully in environments where MRI scans are performed. Clinicians should verify whether the device contains ferromagnetic materials or if it must be removed before MRI procedures. This is important to prevent interference with imaging or potential injury to patients, as reusable endoscopes often undergo imaging or storage near MRI machines.