Celeris
The Celeris System combines a reusable power pack with a disposable sinus debrider. Its handpiece is a single-use handle and blade with a built-in motor that plugs into the power pack. The…
The Celeris System combines a reusable power pack with a disposable sinus debrider. Its handpiece is a single-use handle and blade with a built-in motor that plugs into the power pack.
The filing describes a rotatable blade offered as standard, bipolar, or malleable. Bipolar models use a separate electrosurgical generator connected by cable; that generator is not part of the system.
Listed Item
Disposable Sinus Debrider 4 MM Straight, Standard, Type A Celeris
Procedural Role
The Celeris System is intended for cutting, coagulation, debriding, and removal of thin bone and soft tissue in general ENT and sinus or rhinology procedures, including functional endoscopic sinus surgery and turbinate reduction.
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | ERL |
| Device type | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4250 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K212650 |
| Record published | 2022-02-10 |
| Record revised | 2024-09-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -29 to 60 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 85 % RH |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DSD2000BA | In distribution | ||
| DSD4000BA | 5 | In distribution | |
| DSD4000SA | 5 | In distribution | |
| DSDPP100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ENT MR8 | Medtronic Powered Surgical Solutions | 234 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Anspach Effort, The | 214 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Karl Storz GmbH & Co. KG | 208 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Synthes Gmbh | 126 |
| Midas Rex | Medtronic Powered Surgical Solutions | 97 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Stryker GmbH | 87 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 75 |
| Piezomed Pro Accessory | W&H Dentalwerk Bürmoos GmbH | 50 |
| Midas Rex Clearview™ | Medtronic Xomed, Inc. | 47 |
| Zethon | Zethon Ltd | 39 |
| NSK Sterile Burs/Drills | Nakanishi Inc. | 34 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Medtronic Xomed, Inc. | 29 |
Showing 12 of 169. All products under Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212650 | 2022-01-19 |
| K152744 | 2016-06-10 |
| K121678 | 2012-08-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.