ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Class II
FDA Device Classification
Classification Details
- Product Code
- ERL
- Device Class
- Class II
- Regulation Number
- 874.4250
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243280 | w and h dentalwerk buermoos | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro | July 3, 2025 |
| K233958 | zethon | hekaDrill | March 14, 2024 |
| K221184 | bien-air surgery | ORiGO System | November 2, 2022 |
| K213221 | w and h dentalwerk buermoss | AMADEO, M-UK1015 (incl. attachments and accessories) | May 26, 2022 |
| K212650 | gyrus acmi | Celeris, Disposable Sinus Debrider | January 19, 2022 |
| K211490 | stryker corporation | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Numb | June 9, 2021 |
| K200318 | karl storz endoscopy-america | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver | October 22, 2020 |
| K190715 | interscope | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter | December 13, 2019 |
| K180063 | anspach effort | OCM-G1 Attachment | March 27, 2018 |
| K171840 | stryker corporation | Stryker Consolidated Operating Room Equipment (CORE) 2 Console | September 15, 2017 |
| K163247 | laurimed | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | March 9, 2017 |
| K161376 | grace medical | DragonFly Surgical Drill System | August 25, 2016 |
| K161101 | laurimed | PolypVac Microdebrider (3.3mm and 4.0mm) | June 22, 2016 |
| K152744 | gyrus acmi | DIEGO ELITE DRILL | June 10, 2016 |
| K150969 | karl storz endoscopy america | Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiec | January 8, 2016 |
| K152641 | stryker corporation | Pi Drive Plus Motor, Extender | November 20, 2015 |
| K150728 | medtronic xomed | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | August 14, 2015 |
| K143492 | bien-air surgery | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit | March 4, 2015 |
| K141935 | stryker corporation | STRYKER S2 DRILL | September 26, 2014 |
| K131053 | anspach effort | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | December 31, 2013 |