AMADEO, M-UK1015 (incl. attachments and accessories)
FDA 510(k) K213221 · W&H Dentalwerk Buermoss GmbH
510(k) numberK213221
Submission
- Device name
- AMADEO, M-UK1015 (incl. attachments and accessories)
- Applicant
- W&H Dentalwerk Buermoss GmbH
Buermoos, AT - Received
- September 29, 2021
- Decision date
- May 26, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
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|---|---|---|---|
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…ERL · Traditional | W&H Dentalwerk Buermoos GmbH | 07/03/2025SE |
| K233958 | hekaDrillERL · Traditional | Zethon, Ltd. | 03/14/2024SE |
| K221184 | ORiGO SystemERL · Traditional | Bien-Air Surgery SA | 11/02/2022SE |
| K212650 | Celeris, Disposable Sinus DebriderERL · Traditional | Gyrus Acmi, Inc. | 01/19/2022SE |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number…ERL · Special | Stryker Corporation | 06/09/2021SE |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver HandpieceERL · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/22/2020SE |
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set…ERL · Traditional | Interscope, Inc. | 12/13/2019SE |
| K180063 | OCM-G1 AttachmentERL · Special | The Anspach Effort, Inc. | 03/27/2018SE |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERL · Traditional | Stryker Corporation | 09/15/2017SE |
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderERL · Traditional | Laurimed, LLC | 03/09/2017SE |
More from Laurimed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530)ELC · Traditional | 07/14/2023SE |
Questions and answers
When was AMADEO, M-UK1015 (incl. attachments and accessories) cleared by the FDA?
AMADEO, M-UK1015 (incl. attachments and accessories) (K213221) received a 510(k) decision of Substantially Equivalent on May 26, 2022, 239 days after the submission was received.
What is the product code of K213221?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.