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FDA 510(k)

gastroduodenal FTRD Set

K-Number: K200684 · 2020-06-02

Decision Date2020-06-02
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

gastroduodenal FTRD Set is a medical device manufactured by Ovesco Endoscopy AG. It received FDA 510(k) clearance on 2020-06-02 under approval number K200684. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gastroduodenal FTRD Set?

gastroduodenal FTRD Set is a medical device that received FDA 510(k) clearance on 2020-06-02. It is manufactured by Ovesco Endoscopy AG. The 510(k) number is K200684.

When was gastroduodenal FTRD Set approved by the FDA?

gastroduodenal FTRD Set received FDA 510(k) clearance on 2020-06-02, under approval number K200684.

What company makes gastroduodenal FTRD Set?

gastroduodenal FTRD Set is manufactured by Ovesco Endoscopy AG.

What is the FDA product code for gastroduodenal FTRD Set?

The FDA product code for gastroduodenal FTRD Set is PKL.

Other Devices by Ovesco Endoscopy AG

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Related Devices (Code: PKL)

Official Source

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