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FDA 510(k)

Instrument tray, for semi-rigid ureteroscope

K-Number: K203492 · 2021-09-15

ApplicantOlympus Winter & Ibe GmbH
Decision Date2021-09-15
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Instrument tray, for semi-rigid ureteroscope is a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2021-09-15 under approval number K203492. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Instrument tray, for semi-rigid ureteroscope?

Instrument tray, for semi-rigid ureteroscope is a medical device that received FDA 510(k) clearance on 2021-09-15. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K203492.

When was Instrument tray, for semi-rigid ureteroscope approved by the FDA?

Instrument tray, for semi-rigid ureteroscope received FDA 510(k) clearance on 2021-09-15, under approval number K203492.

What company makes Instrument tray, for semi-rigid ureteroscope?

Instrument tray, for semi-rigid ureteroscope is manufactured by Olympus Winter & Ibe GmbH.

What is the FDA product code for Instrument tray, for semi-rigid ureteroscope?

The FDA product code for Instrument tray, for semi-rigid ureteroscope is KCT.

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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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