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.
Cleared Devices (91)
| 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 |
| K133133 | LAURIMED POLYPVAC MICRODEBRIDER | Laurimed, LLC | Dec 23, 2013 | SESE |
| K121678 | DTAD | Gyrus Acmi, Inc. | Aug 30, 2012 | SESE |
| K112593 | STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Corporation | May 1, 2012 | SESE |
| K083720 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K | Bien-Air Surgery SA | Mar 20, 2009 | SESE |
| K081814 | REPROCESSED ENT SHAVERS | Sterilmed, Inc. | Dec 17, 2008 | SESE |
| K080052 | STRYKER ESSX WITH NAVIGATION MOUNT | Stryker Corp. | Oct 2, 2008 | SESE |
| K080722 | PRIMADO SURGICAL DRILL | Nakanishi, Inc. | Sep 17, 2008 | SESE |
| K081277 | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) | Medtronic Xomed, Inc. | Sep 5, 2008 | SESE |
| K073633 | STRYKER ESSX MICRODEBRIDER SYSTEM | Stryker Ireland Ltd., Instruments Division | Aug 26, 2008 | SESE |
| K073255 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | Mar 24, 2008 | SESE |
| K053262 | KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Dec 19, 2005 | SESE |
| K041523 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | Jul 23, 2004 | SESE |
| K041413 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | Jul 12, 2004 | SESE |
| K040300 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) | Stryker Instruments | Mar 3, 2004 | SESE |
| K034004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE | Gyrus Ent LLC | Mar 3, 2004 | SESE |
| K023070 | SODEM HIGH SPEED SYSTEM (PNEUMATIC) | Sodemsystems | Jan 28, 2003 | SESE |
| K021098 | DAUM-LECTRIC MRI DRILLING MACHINE | Mri Devices Daum GmbH | Dec 3, 2002 | SESE |
| K021811 | UNIDRIVE II PLUS DISPOSABLE TUBING SET | Mtp Medical Technical Promotion GmbH | Jun 19, 2002 | SESE |
| K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM | Gyrus Ent LLC | Mar 8, 2002 | SESE |
| K012456 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) | Sodemsystems | Sep 21, 2001 | SESE |
| K011321 | MODIFICATION TO XPS 3000 SYSTEM | Medtronic Xomed, Inc. | Jun 26, 2001 | SESE |
| K011381 | HUMMER IV MICRODEBRIDER SYSTEM | Stryker Instruments | May 25, 2001 | SESE |
| K003994 | KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Apr 13, 2001 | SESE |
| K002224 | XPS 3000 SYSTEM | Medtronic Xomed | Dec 4, 2000 | SESE |
| K002828 | XPS NITRO SYSTEM | Xomed, Inc. | Oct 17, 2000 | SESE |
| K992994 | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; | Gyrus Ent LLC | Nov 23, 1999 | SESE |
| K990038 | HUMMER TRAK SYSTEM | Stryker Endoscopy | Feb 19, 1999 | SESE |
| K983050 | PNEUMATIC CUTTER SYSTEM | Surgical Laser Technologies, Inc. | Nov 25, 1998 | SESE |
| K983224 | XPS DRILL SYSTEM | Xomed, Inc. | Oct 21, 1998 | SESE |
| K981041 | SLT BIPOLAR SHEATH | Surgical Laser Technologies, Inc. | Aug 27, 1998 | SESE |
| K981637 | INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY | Linvatec Corp. | Jul 20, 1998 | SESE |
| K974174 | ULTRABUR | Mednet Locator, Inc. | Mar 10, 1998 | SESE |
| K972057 | POWERTREK INSTRUMENTS | Medtrek Corp. | Nov 5, 1997 | SESE |
| K972584 | STRYKER HUMMER II MICRODEBRIDER SYSTEM | Stryker Endoscopy | Oct 1, 1997 | SESE |
| K973286 | ENT IRRIGATING PUMP (70327700) | Gyrus Ent LLC | Sep 29, 1997 | SESE |
| K972865 | PROMEX ENT TISSUE REMOVAL SYSTEM | Promex, Inc. | Sep 29, 1997 | SESE |
| K972453 | XPS STRAIGHTSHOT MICRORESECTOR | Xomed, Inc. | Sep 5, 1997 | SESE |
| K970965 | MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) | Midas Rex Pneumatic Tools, Inc. | Apr 9, 1997 | SESE |
| K964548 | APEX UNIVERSAL DRIVE SYSTEM | Linvatec Corp. | Jan 17, 1997 | SESE |
| K965080 | ANSPACH MICROMAX SYSTEM | The Anspach Effort, Inc. | Jan 10, 1997 | SESE |
| K963246 | TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT | Medtronic Xomed | Sep 23, 1996 | SESE |
| K962163 | MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL | Misten Medical Corp. | Jul 25, 1996 | SESE |
| K961192 | IRRIGATION SYSTEM | Linvatec Corp. | Apr 26, 1996 | SESE |
| K954989 | DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES | Smith & Nephew Dyonics, Inc. | Nov 27, 1995 | SESE |
| K954796 | MICRO-INGRESSOR HANDIPIECE | Trebay Medical Corp. | Nov 6, 1995 | SESE |
| K954715 | MICRO-PLANER HANDPIECE | Trebay Medical Corp. | Oct 27, 1995 | SESE |
| K952681 | STRYKER HUMMER II MICRODEBRIDER SYSTEM | Stryker Endoscopy | Jul 20, 1995 | SESE |
| K951263 | INTRAARC DRIVE SYSTEM | Linvatec Corp. | Apr 17, 1995 | SESE |
| K950964 | KARL STORZ INTRA-HANDPIECES AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | Mar 24, 1995 | SESE |
| K945659 | BLACKSTAR(TM) STAR SYSTEM | Xomed-Treace, Inc. | Jan 9, 1995 | SESE |
| K943569 | STRYKER TOTAL PERFORMANCE SYSTEM | Stryker Corp. | Jan 9, 1995 | SESE |
| K945438 | EDI-BUR MICRODRILL SYSTEMS | Micromed Development Corp. | Nov 22, 1994 | SESE |
| K940016 | ELECTRIC SURGICAL DRILL | Alamo City Dental Supply Co. | Nov 22, 1994 | SESE |
| K944476 | APEX UNIVERSAL DRIVE SYSTEM | Linvatec Corp. | Nov 18, 1994 | SESE |
| K943108 | MEDNEXT MICRO-DRILL | Mednext, Inc. | Aug 17, 1994 | SESE |
| K940710 | STRYKER MICRODEBRIDER SYSTEM | Stryker Corp. | May 16, 1994 | SESE |
| K914346 | DRILL MODULES MODELS 2116/2117 | Micro Surgical Instruments Corp. | Nov 27, 1991 | SESE |
| K905800 | X-T AIR DRILL | Xomed-Treace, Inc. | Apr 22, 1991 | SESE |
| K873154 | TREACE MAGNUM OTO-TOOL SYSTEM | Treace Medical, Inc. | Sep 4, 1987 | SESE |
| K862807 | TREACE DRILL SYSTEM | Treace Medical, Inc. | Aug 15, 1986 | SESE |
| K854332 | MICRO-AIRE STAPES DRILL SYSTEM | Micro-Aire Surgical Instruments, Inc. | Jan 21, 1986 | SESE |
| K854331 | MICRO-AIRE OTO/NEURO DRILL SYSTEM | Micro-Aire Surgical Instruments, Inc. | Jan 21, 1986 | SESE |
| K841813 | TISSUE INTEGRATED PROSTHESIS DRILL | Bofors Nobelpharma, Inc. | Aug 10, 1984 | SESE |
| K833875 | SHEA FOOTPLATE MICRODRILL | Applied Research Corp. | Jun 22, 1984 | SESE |
| K833874 | SHEA MIDDLE EAR MICRODRILL | Applied Research Corp. | Jun 22, 1984 | SESE |
| K831946 | SURGICAL DRILL-ELECTRIC-HANDPIECE | Entronics | Nov 3, 1983 | SESE |
| K822008 | TORX OR TYPE MICRO MOTOR HANDPIECE | Kelleher Corp. | Aug 12, 1982 | SESE |
| K802463 | MICRO-SURGICAL POWER INSTRUMENT SYSTEM | Spire Medical, Inc. | Oct 31, 1980 | SESE |
| K792159 | FISCH DRILL SYSTEM | Jedmed Instrument Co. | Nov 27, 1979 | SESE |
| K791407 | WOMED NICRO-CRAFT POWER SYSTEM | Xomed, Inc. | Aug 22, 1979 | SESE |
| K781418 | XOMED TRANSSPHENOIDAL HANDPIECE | Xomed, Inc. | Aug 31, 1978 | 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
