ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Class II
FDA product code ERL covers "Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece", a Class II medical device regulated under 21 CFR 874.4250. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |