Product code ERL
- Device name
- Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.4250
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | W&H Dentalwerk Buermoos GmbH | 2025-07-03 |
| K233958 | hekaDrill | Zethon, Ltd. | 2024-03-14 |
| K221184 | ORiGO System | Bien-Air Surgery SA | 2022-11-02 |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | 2022-05-26 |
| K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | 2022-01-19 |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 | Stryker Corporation | 2021-06-09 |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | KARL STORZ Endoscopy-America, Inc. | 2020-10-22 |
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand | Interscope, Inc. | 2019-12-13 |
| K180063 | OCM-G1 Attachment | The Anspach Effort, Inc. | 2018-03-27 |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Corporation | 2017-09-15 |
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | Laurimed, LLC | 2017-03-09 |
| K161376 | DragonFly Surgical Drill System | Grace Medical, Inc. | 2016-08-25 |
| K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) | Laurimed, LLC | 2016-06-22 |
| K152744 | DIEGO ELITE DRILL | Gyrus Acmi, Inc. | 2016-06-10 |
| 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. | 2016-01-08 |
| K152641 | Pi Drive Plus Motor, Extender | Stryker Corporation | 2015-11-20 |
| K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | Medtronic Xomed, Inc. | 2015-08-14 |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece | Bien-Air Surgery SA | 2015-03-04 |
| K141935 | STRYKER S2 DRILL | Stryker Corporation | 2014-09-26 |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | The Anspach Effort, Inc. | 2013-12-31 |
| K133133 | LAURIMED POLYPVAC MICRODEBRIDER | Laurimed, LLC | 2013-12-23 |
| K121678 | DTAD | Gyrus Acmi, Inc. | 2012-08-30 |
| K112593 | STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Corporation | 2012-05-01 |
| K083720 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K | Bien-Air Surgery SA | 2009-03-20 |
| K081814 | REPROCESSED ENT SHAVERS | Sterilmed, Inc. | 2008-12-17 |
| K080052 | STRYKER ESSX WITH NAVIGATION MOUNT | Stryker Corp. | 2008-10-02 |
| K080722 | PRIMADO SURGICAL DRILL | Nakanishi, Inc. | 2008-09-17 |
| K081277 | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) | Medtronic Xomed, Inc. | 2008-09-05 |
| K073633 | STRYKER ESSX MICRODEBRIDER SYSTEM | Stryker Ireland Ltd., Instruments Division | 2008-08-26 |
| K073255 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2008-03-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04589551366361 | P300-2S120 | NAKANISHI INC. | 2026-06-26 |
| 04589551366316 | P300-2S100 | NAKANISHI INC. | 2026-06-26 |
| 04589551366262 | P300-2A120 | NAKANISHI INC. | 2026-06-26 |
| 04589551366217 | P300-2A100 | NAKANISHI INC. | 2026-06-26 |
| 00821925033900 | DIEGO | Gyrus ACMI, LLC | 2024-07-25 |
| 00821925033917 | DIEGO | Gyrus ACMI, LLC | 2024-07-24 |
| 00821925034419 | DIEGO | Gyrus ACMI, LLC | 2024-07-23 |
| 00821925011441 | DIEGO | Gyrus ACMI, LLC | 2017-05-11 |
| 00821925011410 | DIEGO | Gyrus ACMI, LLC | 2016-10-12 |
| 00821925028746 | Diego | Gyrus ACMI, LLC | 2016-10-06 |
| 10886982065148 | NA | Synthes GmbH | 2016-06-30 |
| 10886982065131 | NA | Synthes GmbH | 2016-06-30 |
| 10886982065094 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065087 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065070 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065063 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065049 | NA | Synthes GmbH | 2016-06-30 |
| 10886982065032 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982065001 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064943 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064936 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064929 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064912 | NA | Synthes GmbH | 2016-06-30 |
| 10886982064905 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064882 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064844 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064820 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064745 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982064738 | NA | Synthes GmbH | 2016-06-30 |
| 10886982064721 | NA | Synthes GmbH | 2016-06-30 |