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FDA 510(k)

OES Elite Ureteroscopes and Accessories

K-Number: K200369 · 2020-08-28

ApplicantOlympus Winter & Ibe GmbH
Decision Date2020-08-28
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OES Elite Ureteroscopes and Accessories is a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2020-08-28 under approval number K200369. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OES Elite Ureteroscopes and Accessories?

OES Elite Ureteroscopes and Accessories is a medical device that received FDA 510(k) clearance on 2020-08-28. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K200369.

When was OES Elite Ureteroscopes and Accessories approved by the FDA?

OES Elite Ureteroscopes and Accessories received FDA 510(k) clearance on 2020-08-28, under approval number K200369.

What company makes OES Elite Ureteroscopes and Accessories?

OES Elite Ureteroscopes and Accessories is manufactured by Olympus Winter & Ibe GmbH.

What is the FDA product code for OES Elite Ureteroscopes and Accessories?

The FDA product code for OES Elite Ureteroscopes and Accessories is FGB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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