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FDA 510(k)

Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2

K-Number: K212296 · 2021-08-19

ApplicantFujifilm Corporation
Decision Date2021-08-19
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K212296. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2?

Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Fujifilm Corporation. The 510(k) number is K212296.

When did Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 receive FDA 510(k) clearance?

Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 received FDA 510(k) clearance on 2021-08-19, under 510(k) number K212296.

Who is the listed applicant for Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2?

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

What is the FDA product code for Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2?

The FDA product code for Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 is FDS.

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Related Devices (Code: FDS)

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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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