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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 the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2021-01-21 under 510(k) 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. The listed applicant is Aesculap, Inc.. The 510(k) number is K202391.

When did DIR 800 receive FDA 510(k) clearance?

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

Who is the listed applicant for DIR 800?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIR 800?

The FDA product code for DIR 800 is IZI.

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Related Devices (Code: 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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