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 a medical device manufactured by Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2022-01-19 under approval 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. It is manufactured by Gyrus Acmi, Inc.. The 510(k) number is K212650.
When was Celeris, Disposable Sinus Debrider approved by the FDA?
Celeris, Disposable Sinus Debrider received FDA 510(k) clearance on 2022-01-19, under approval number K212650.
What company makes Celeris, Disposable Sinus Debrider?
Celeris, Disposable Sinus Debrider is manufactured by Gyrus Acmi, Inc..
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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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.