Torx or Type Micro Motor Handpiece
FDA 510(k) K822008 · Kelleher Corp.
510(k) numberK822008
Submission
- Device name
- Torx or Type Micro Motor Handpiece
- Applicant
- Kelleher Corp.
Mchenry, IL, US - Received
- July 8, 1982
- Decision date
- August 12, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code ERL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
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| K233958 | hekaDrillERL · Traditional | Zethon, Ltd. | 03/14/2024SE |
| K221184 | ORiGO SystemERL · Traditional | Bien-Air Surgery SA | 11/02/2022SE |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories)ERL · Traditional | W&H Dentalwerk Buermoss GmbH | 05/26/2022SE |
| 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 |
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| 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 |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K822618 | Emergency Tracheostomy Instrument SetLJW · Traditional | 01/28/1983SE |
| K822268 | Nagashima Ns-Iii ElectronystagmographGWN · Traditional | 01/28/1983SE |
| K823083 | Electrosurgical UnitGEI · Traditional | 12/07/1982SE |
| K823111 | Nystymograph AccessGNN · Traditional | 11/22/1982SE |
| K822252 | ENT Treatment UnitsETF · Traditional | 11/22/1982SE |
| K822272 | Head Mirrors W/Head Lamps & Head BandsHPQ · Traditional | 11/10/1982SE |
| K822017 | Tympanostomy Tubes & Various TypesETD · Traditional | 10/27/1982SE |
| K822257 | Various Types of Light Source HandlesEOQ · Traditional | 10/26/1982SE |
| K822259 | Laryngeal SpatulasEQH · Traditional | 10/22/1982SE |
| K822004 | Face ShieldsKNT · Traditional | 10/20/1982SE |
Questions and answers
When was Torx or Type Micro Motor Handpiece cleared by the FDA?
Torx or Type Micro Motor Handpiece (K822008) received a 510(k) decision of Substantially Equivalent on August 12, 1982, 35 days after the submission was received.
What is the product code of K822008?
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.