Celeris Disposable Sinus Debrider
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212650 FDA 510(k)
- FDA Product Code
- ERL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4250 FDA 510(k)
- Regulation Number
- 874.4250 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Celeris Disposable Sinus Debrider is a single-use, electric or pneumatic surgical device classified as a Drill, Surgical, ENT (Electric or Pneumatic) Including Handpiece (Product Code: ERL). It is designed for sinus debridement procedures, providing precise tissue removal and clearance of sinus cavities. This device is intended for use in otolaryngology (ENT) applications, where minimally invasive resection and cleaning are required. Its disposable design eliminates the need for reprocessing, ensuring sterility and reducing cross-contamination risks.
The Celeris Disposable Sinus Debrider is supplied as a sterile, single-use device, intended for use in operating room settings by trained medical professionals. It operates under 21 CFR 874.4250 and has received FDA 510(k) clearance as substantially equivalent to prior-generation devices. The device is not MRI-compatible and must be used in accordance with manufacturer instructions. Each unit is pre-packaged for immediate clinical use, ensuring readiness for ENT surgical procedures.
Frequently asked questions
What is the Celeris Disposable Sinus Debrider used for?
The Celeris Disposable Sinus Debrider is designed specifically for sinus debridement procedures in otolaryngology (ENT) settings. It provides precise tissue removal and clearance of sinus cavities, enabling minimally invasive resection and cleaning during surgical interventions. Its primary purpose is to enhance procedural efficiency while reducing the risk of contamination.
Is the Celeris Disposable Sinus Debrider single-use or reusable?
The Celeris Disposable Sinus Debrider is a single-use device. This design eliminates the need for reprocessing, ensuring consistent sterility and reducing the risk of cross-contamination between patients. Each unit is pre-packaged for immediate clinical use, making it ideal for operating room settings.
How is the Celeris Disposable Sinus Debrider supplied?
The device is supplied as a sterile, single-use unit, pre-packaged and ready for immediate use in operating rooms. This packaging ensures that the device maintains its sterility until deployment, adhering to best practices for surgical instruments in ENT procedures.
Can the Celeris Disposable Sinus Debrider be used with MRI equipment?
No, the Celeris Disposable Sinus Debrider is not MRI-compatible. It must be used strictly in accordance with the manufacturer’s instructions, which specify its intended use in non-MRI environments to avoid interference or safety risks.
What regulatory pathway does the Celeris Disposable Sinus Debrider follow?
The Celeris Disposable Sinus Debrider has received FDA 510(k) clearance, demonstrating its substantial equivalence to prior-generation devices under 21 CFR 874.4250. This classification ensures it meets regulatory standards for surgical drills in ENT applications, including electric or pneumatic handpieces.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Celeris, Disposable Sinus Debrider (K212650) — FDA 510 (k) | Innolitics, CELERIS Disposable Sinus Debrider | Olympus America | Medical, K212650 FDA 510 (k) - Celeris | Gyrus Acmi, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212650 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA 510(k) K212650 24 fields · synced Oct 1, 2026