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FDA 510(k)

DIR 800

K-Number: K202391 · 2021-01-21

ApplicantAesculap, Inc.
Decision Date2021-01-21
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIR 800 is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2021-01-21 under approval number K202391. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIR 800?

DIR 800 is a medical device that received FDA 510(k) clearance on 2021-01-21. It is manufactured by Aesculap, Inc.. The 510(k) number is K202391.

When was DIR 800 approved by the FDA?

DIR 800 received FDA 510(k) clearance on 2021-01-21, under approval number K202391.

What company makes DIR 800?

DIR 800 is manufactured by Aesculap, Inc..

What is the FDA product code for DIR 800?

The FDA product code for DIR 800 is IZI.

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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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