ERL · Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Ear, Nose, Throat · 21 CFR 874.4250 · Class 2
Overview
| Product Code | ERL |
|---|---|
| Device Name | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece |
| Regulation | 21 CFR 874.4250 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
Identification
An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 91)
Showing 20 most recent of 91 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | W&H Dentalwerk Buermoos GmbH | Jul 3, 2025 | SESE |
| K233958 | hekaDrill | Zethon, Ltd. | Mar 14, 2024 | SESE |
| K221184 | ORiGO System | Bien-Air Surgery SA | Nov 2, 2022 | SESE |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | May 26, 2022 | SESE |
| K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | Jan 19, 2022 | SESE |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 | Stryker Corporation | Jun 9, 2021 | SESE |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | KARL STORZ Endoscopy-America, Inc. | Oct 22, 2020 | SESE |
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand | Interscope, Inc. | Dec 13, 2019 | SESE |
| K180063 | OCM-G1 Attachment | The Anspach Effort, Inc. | Mar 27, 2018 | SESE |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Corporation | Sep 15, 2017 | SESE |
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | Laurimed, LLC | Mar 9, 2017 | SESE |
| K161376 | DragonFly Surgical Drill System | Grace Medical, Inc. | Aug 25, 2016 | SESE |
| K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) | Laurimed, LLC | Jun 22, 2016 | SESE |
| K152744 | DIEGO ELITE DRILL | Gyrus Acmi, Inc. | Jun 10, 2016 | SESE |
| K150969 | Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces | Karl Storz Endoscopy America, Inc. | Jan 8, 2016 | SESE |
| K152641 | Pi Drive Plus Motor, Extender | Stryker Corporation | Nov 20, 2015 | SESE |
| K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | Medtronic Xomed, Inc. | Aug 14, 2015 | SESE |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece | Bien-Air Surgery SA | Mar 4, 2015 | SESE |
| K141935 | STRYKER S2 DRILL | Stryker Corporation | Sep 26, 2014 | SESE |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | The Anspach Effort, Inc. | Dec 31, 2013 | SESE |
Top Applicants
- Medtronic Xomed, Inc. — 6 clearances
- Xomed, Inc. — 5 clearances
- Stryker Corporation — 5 clearances
- Linvatec Corp. — 5 clearances
- KARL STORZ Endoscopy-America, Inc. — 4 clearances
