FDA 510(k) Applications for Medical Device Product Code "ERL"
(Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K221184 | Bien-Air Surgery SA | ORiGO System | 11/02/2022 |
| K083720 | BIEN-AIR SURGERY SA | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K | 03/20/2009 |
| K143492 | Bien-Air Surgery SA | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece | 03/04/2015 |
| K161376 | Grace Medical, Inc. | DragonFly Surgical Drill System | 08/25/2016 |
| K152744 | GYRUS ACMI, INC | DIEGO ELITE DRILL | 06/10/2016 |
| K212650 | Gyrus ACMI, Inc. | Celeris, Disposable Sinus Debrider | 01/19/2022 |
| K121678 | GYRUS ACMI, INC. | DTAD | 08/30/2012 |
| K020594 | GYRUS ENT L.L.C. | DIEGO POWERED DISSECTOR AND DRILL SYSTEM | 03/08/2002 |
| K034004 | GYRUS ENT L.L.C. | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE | 03/03/2004 |
| K973286 | GYRUS ENT L.L.C. | ENT IRRIGATING PUMP (70327700) | 09/29/1997 |
| K992994 | GYRUS ENT L.L.C. | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; | 11/23/1999 |
| K190715 | Interscope, Inc. | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand | 12/13/2019 |
| K150969 | KARL STORZ ENDOSCOPY AMERICA, INC. | 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 | 01/08/2016 |
| K053262 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES | 12/19/2005 |
| K003994 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES | 04/13/2001 |
| K200318 | Karl Storz Endoscopy-America, Inc. | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | 10/22/2020 |
| K163247 | LAURIMED LLC | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | 03/09/2017 |
| K133133 | LAURIMED LLC | LAURIMED POLYPVAC MICRODEBRIDER | 12/23/2013 |
| K161101 | LAURIMED LLC | PolypVac Microdebrider (3.3mm and 4.0mm) | 06/22/2016 |
| K964548 | LINVATEC CORP. | APEX UNIVERSAL DRIVE SYSTEM | 01/17/1997 |
| K981637 | LINVATEC CORP. | INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY | 07/20/1998 |
| K961192 | LINVATEC CORP. | IRRIGATION SYSTEM | 04/26/1996 |
| K974174 | MEDNET LOCATOR, INC. | ULTRABUR | 03/10/1998 |
| K972057 | MEDTREK CORP. | POWERTREK INSTRUMENTS | 11/05/1997 |
| K963246 | MEDTRONIC XOMED | TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT | 09/23/1996 |
| K002224 | MEDTRONIC XOMED | XPS 3000 SYSTEM | 12/04/2000 |
| K011321 | MEDTRONIC XOMED, INC. | MODIFICATION TO XPS 3000 SYSTEM | 06/26/2001 |
| K041413 | MEDTRONIC XOMED, INC. | XPS 3000 SYSTEM | 07/12/2004 |
| K041523 | MEDTRONIC XOMED, INC. | XPS 3000 SYSTEM | 07/23/2004 |
| K073255 | MEDTRONIC XOMED, INC. | XPS 3000 SYSTEM | 03/24/2008 |
| K081277 | MEDTRONIC XOMED, INC. | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) | 09/05/2008 |
| K150728 | MEDTRONIC XOMED, INC. | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | 08/14/2015 |
| K970965 | MIDAS REX PNEUMATIC TOOLS, INC. | MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) | 04/09/1997 |
| K962163 | MISTEN MEDICAL CORP. | MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL | 07/25/1996 |
| K021098 | MRI DEVICES DAUM GMBH | DAUM-LECTRIC MRI DRILLING MACHINE | 12/03/2002 |
| K021811 | MTP MEDICAL TECHNICAL PROMOTION GMBH | UNIDRIVE II PLUS DISPOSABLE TUBING SET | 06/19/2002 |
| K080722 | NAKANISHI, INC. | PRIMADO SURGICAL DRILL | 09/17/2008 |
| K972865 | PROMEX, INC. | PROMEX ENT TISSUE REMOVAL SYSTEM | 09/29/1997 |
| K012456 | SODEM SYSTEMS | SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) | 09/21/2001 |
| K023070 | SODEM SYSTEMS | SODEM HIGH SPEED SYSTEM (PNEUMATIC) | 01/28/2003 |
| K081814 | STERILMED, INC. | REPROCESSED ENT SHAVERS | 12/17/2008 |
| K080052 | STRYKER CORP. | STRYKER ESSX WITH NAVIGATION MOUNT | 10/02/2008 |
| K211490 | Stryker Corporation | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 | 06/09/2021 |
| K152641 | STRYKER CORPORATION | Pi Drive Plus Motor, Extender | 11/20/2015 |
| K171840 | Stryker Corporation | Stryker Consolidated Operating Room Equipment (CORE) 2 Console | 09/15/2017 |
| K141935 | STRYKER CORPORATION | STRYKER S2 DRILL | 09/26/2014 |
| K112593 | STRYKER CORPORATION | STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | 05/01/2012 |
| K990038 | Stryker Endoscopy | HUMMER TRAK SYSTEM | 02/19/1999 |
| K972584 | Stryker Endoscopy | STRYKER HUMMER II MICRODEBRIDER SYSTEM | 10/01/1997 |
| K011381 | STRYKER INSTRUMENTS | HUMMER IV MICRODEBRIDER SYSTEM | 05/25/2001 |
| K040300 | STRYKER INSTRUMENTS | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) | 03/03/2004 |
| K073633 | STRYKER IRELAND LTD., INSTRUMENTS DIVISION | STRYKER ESSX MICRODEBRIDER SYSTEM | 08/26/2008 |
| K983050 | SURGICAL LASER TECHNOLOGIES, INC. | PNEUMATIC CUTTER SYSTEM | 11/25/1998 |
| K981041 | SURGICAL LASER TECHNOLOGIES, INC. | SLT BIPOLAR SHEATH | 08/27/1998 |
| K965080 | THE ANSPACH EFFORT, INC. | ANSPACH MICROMAX SYSTEM | 01/10/1997 |
| K131053 | THE ANSPACH EFFORT, INC. | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | 12/31/2013 |
| K180063 | The Anspach Effort, Inc. | OCM-G1 Attachment | 03/27/2018 |
| K213221 | W&H Dentalwerk Buermoss GmbH | AMADEO, M-UK1015 (incl. attachments and accessories) | 05/26/2022 |
| K983224 | XOMED, INC. | XPS DRILL SYSTEM | 10/21/1998 |
| K002828 | XOMED, INC. | XPS NITRO SYSTEM | 10/17/2000 |
| K972453 | XOMED, INC. | XPS STRAIGHTSHOT MICRORESECTOR | 09/05/1997 |
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