FDA 510(k)

PROBE ULTRASONIQUE UM-3R (UM-3R); PROBE ULTRASONIQUE UM-G20-29R (UM-G20-29R)

Numéro K : K250883 · 2025-09-18

DemandeurOlympus Medical Systems Corporation

Date de décision2025-09-18

Code produitITX

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-09-18 under 510(k) number K250883. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)?

ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) is a medical device that received FDA 510(k) clearance on 2025-09-18. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K250883.

When did ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) receive FDA 510(k) clearance?

ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) received FDA 510(k) clearance on 2025-09-18, under 510(k) number K250883.

Who is the listed applicant for ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)?

The FDA product code for ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) is ITX.

Essais cliniques associés

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Source officielle

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