Submission Details
| 510(k) Number | K212650 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 23, 2021 |
| Decision Date | January 19, 2022 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
Cleared
Traditional
Celeris, Disposable Sinus Debrider
Jan 2022
Decision
149d
Days
Class 2
Risk
About This 510(k) Submission
K212650 is an FDA 510(k) clearance for the Celeris, Disposable Sinus Debrider, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Gyrus Acmi, Inc. (Westborough, US). The FDA issued a Cleared decision on January 19, 2022, 149 days after receiving the submission on August 23, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.
Device Classification
| Product Code | ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.4250 |
Manufacturer
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