# K212650: Celeris, Disposable Sinus Debrider

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jan 19, 2022 after 149 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K936109 (1994). 97 ancestors in all.
No later device cites it as a predicate yet.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123429: Olympus Energy Power System (Eps), Gyrus Acmi, Inc. (2013) Summary page 5.
- K034004: Diego RF Powered Dissector and Drill System Console, Gyrus Ent LLC (2004) Summary page 5.

## Indications for use
The Celeris System (reusable power pack and Disposable Sinus Debrider) is intended for cutting, coagulation, debriding, and removal of thin bone and soft tissue in general ENT and Sinus/Rhinology procedures. Specific procedures and applications would include: * FESS (Functional Endoscopic Sinus Surgery) — Including Endoscopic approaches for: Polypectomy, Ethmoidectomy, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy * Turbinate Reduction / Turbinoplasty, including sub-mucosal resection.

Source page: https://510kreport.com/device/K212650
Methodology: https://510kreport.com/methodology