Celeris, Disposable Sinus Debrider— 510(k) K212650

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K212650 for Celeris, Disposable Sinus Debrider, Substantially Equivalent on 2022-01-19. Applicant: Gyrus Acmi, Inc..

Clearance details

Applicant: Gyrus Acmi, Inc.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2021-08-23
Decision date: 2022-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.