Olympus Switching Unit Model SU-1

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

510(k) Number

K944081 ↗

FDA Product Code

FET

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 America, Inc. →

• What is the Olympus Switching Unit Model SU-1 used for?

  The Olympus Switching Unit Model SU-1 is an endoscopic video imaging system component designated for use in the medical specialties of gastroenterology and urology, as classified under regulation number 876.1500, to support video imaging during endoscopic procedures in these fields.

• When did the Olympus Switching Unit Model SU-1 receive FDA clearance and what was the submission type?

  The Olympus Switching Unit Model SU-1 received FDA 510(k) clearance K944081 on November 14, 1994, following a traditional 510(k) submission, and was found substantially equivalent to a predicate device.

• What is the device classification and product code for the Olympus Switching Unit Model SU-1?

  The Olympus Switching Unit Model SU-1 is classified as a Class II device with product code FET, as determined by its FDA 510(k) clearance under regulation number 876.1500 for endoscopic video imaging system/components.