The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Celeris, Disposable Sinus Debrider.
| Device ID | K212650 |
| 510k Number | K212650 |
| Device Name: | Celeris, Disposable Sinus Debrider |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | Gyrus ACMI, Inc. 800 West Park Drive Westborough, MA 01581 |
| Contact | Dolan Mills |
| Correspondent | Dolan Mills Gyrus ACMI, Inc. 800 West Park Drive Westborough, MA 01581 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2022-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925045163 | K212650 | 000 |
| 00821925044944 | K212650 | 000 |
| 00821925044906 | K212650 | 000 |
| 00821925044883 | K212650 | 000 |
| 00821925044876 | K212650 | 000 |