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FDA 510(k)

Celeris, Disposable Sinus Debrider

K-Number: K212650 · 2022-01-19

ApplicantGyrus Acmi, Inc.
Decision Date2022-01-19
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Celeris, Disposable Sinus Debrider is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K212650. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celeris, Disposable Sinus Debrider?

Celeris, Disposable Sinus Debrider is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K212650.

When did Celeris, Disposable Sinus Debrider receive FDA 510(k) clearance?

Celeris, Disposable Sinus Debrider received FDA 510(k) clearance on 2022-01-19, under 510(k) number K212650.

Who is the listed applicant for Celeris, Disposable Sinus Debrider?

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

What is the FDA product code for Celeris, Disposable Sinus Debrider?

The FDA product code for Celeris, Disposable Sinus Debrider is ERL.

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Related Devices (Code: ERL)

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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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