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FDA 510(k)

Sheath, Stopcock Accessory

K-Number: K213207 · 2021-12-22

ApplicantOlympus Winter & Ibe GmbH
Decision Date2021-12-22
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sheath, Stopcock Accessory is a medical device manufactured by Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2021-12-22 under approval number K213207. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sheath, Stopcock Accessory?

Sheath, Stopcock Accessory is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Olympus Winter & Ibe GmbH. The 510(k) number is K213207.

When was Sheath, Stopcock Accessory approved by the FDA?

Sheath, Stopcock Accessory received FDA 510(k) clearance on 2021-12-22, under approval number K213207.

What company makes Sheath, Stopcock Accessory?

Sheath, Stopcock Accessory is manufactured by Olympus Winter & Ibe GmbH.

What is the FDA product code for Sheath, Stopcock Accessory?

The FDA product code for Sheath, Stopcock Accessory is HIH.

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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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