FDA Product Code
FDA Product Code ERL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4250
510(k) Clearances — 91 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Traditional | PDF ↗ |
| K233958 | hekaDrill | Zethon, Ltd. | 2024-03-14 | Traditional | PDF ↗ |
| K221184 | ORiGO System | Bien-Air Surgery SA | 2022-11-02 | Traditional | PDF ↗ |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | 2022-05-26 | Traditional | PDF ↗ |
| K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | 2022-01-19 | Traditional | PDF ↗ |
| 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 | Special | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand | Interscope, Inc. | 2019-12-13 | Traditional | PDF ↗ |
| K180063 | OCM-G1 Attachment | The Anspach Effort, Inc. | 2018-03-27 | Special | PDF ↗ |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Corporation | 2017-09-15 | Traditional | PDF ↗ |
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | Laurimed, LLC | 2017-03-09 | Traditional | PDF ↗ |
| K161376 | DragonFly Surgical Drill System | Grace Medical, Inc. | 2016-08-25 | Traditional | PDF ↗ |
| K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) | Laurimed, LLC | 2016-06-22 | Special | PDF ↗ |
| K152744 | DIEGO ELITE DRILL | Gyrus Acmi, Inc. | 2016-06-10 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K152641 | Pi Drive Plus Motor, Extender | Stryker Corporation | 2015-11-20 | Special | PDF ↗ |
| K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole | Medtronic Xomed, Inc. | 2015-08-14 | Traditional | PDF ↗ |
| K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece | Bien-Air Surgery SA | 2015-03-04 | Traditional | PDF ↗ |
| K141935 | STRYKER S2 DRILL | Stryker Corporation | 2014-09-26 | Special | PDF ↗ |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | The Anspach Effort, Inc. | 2013-12-31 | Traditional | PDF ↗ |
| K133133 | LAURIMED POLYPVAC MICRODEBRIDER | Laurimed, LLC | 2013-12-23 | Traditional | PDF ↗ |
| K121678 | DTAD | Gyrus Acmi, Inc. | 2012-08-30 | Traditional | PDF ↗ |
| K112593 | STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Corporation | 2012-05-01 | Traditional | PDF ↗ |
| K083720 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K | Bien-Air Surgery SA | 2009-03-20 | Traditional | PDF ↗ |
| K081814 | REPROCESSED ENT SHAVERS | Sterilmed, Inc. | 2008-12-17 | Traditional | PDF ↗ |
| K080052 | STRYKER ESSX WITH NAVIGATION MOUNT | Stryker Corp. | 2008-10-02 | Traditional | PDF ↗ |
| K080722 | PRIMADO SURGICAL DRILL | Nakanishi, Inc. | 2008-09-17 | Traditional | PDF ↗ |
| K081277 | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) | Medtronic Xomed, Inc. | 2008-09-05 | Traditional | PDF ↗ |
| K073633 | STRYKER ESSX MICRODEBRIDER SYSTEM | Stryker Ireland Ltd., Instruments Division | 2008-08-26 | Traditional | PDF ↗ |
| K073255 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2008-03-24 | Traditional | PDF ↗ |
| K053262 | KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2005-12-19 | Traditional | PDF ↗ |
| K041523 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2004-07-23 | Traditional | PDF ↗ |
| K041413 | XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2004-07-12 | Traditional | PDF ↗ |
| K034004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE | Gyrus Ent LLC | 2004-03-03 | Traditional | PDF ↗ |
| K040300 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) | Stryker Instruments | 2004-03-03 | Traditional | PDF ↗ |
| K023070 | SODEM HIGH SPEED SYSTEM (PNEUMATIC) | Sodemsystems | 2003-01-28 | Traditional | PDF ↗ |
| K021098 | DAUM-LECTRIC MRI DRILLING MACHINE | Mri Devices Daum GmbH | 2002-12-03 | Traditional | PDF ↗ |
| K021811 | UNIDRIVE II PLUS DISPOSABLE TUBING SET | Mtp Medical Technical Promotion GmbH | 2002-06-19 | Traditional | PDF ↗ |
| K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM | Gyrus Ent LLC | 2002-03-08 | Traditional | PDF ↗ |
| K012456 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) | Sodemsystems | 2001-09-21 | Traditional | PDF ↗ |
| K011321 | MODIFICATION TO XPS 3000 SYSTEM | Medtronic Xomed, Inc. | 2001-06-26 | Traditional | PDF ↗ |
| K011381 | HUMMER IV MICRODEBRIDER SYSTEM | Stryker Instruments | 2001-05-25 | Traditional | PDF ↗ |
| K003994 | KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 2001-04-13 | Traditional | PDF ↗ |
| K002224 | XPS 3000 SYSTEM | Medtronic Xomed | 2000-12-04 | Traditional | PDF ↗ |
| K002828 | XPS NITRO SYSTEM | Xomed, Inc. | 2000-10-17 | Traditional | PDF ↗ |
| K992994 | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; | Gyrus Ent LLC | 1999-11-23 | Traditional | PDF ↗ |
| K990038 | HUMMER TRAK SYSTEM | Stryker Endoscopy | 1999-02-19 | Traditional | PDF ↗ |
| K983050 | PNEUMATIC CUTTER SYSTEM | Surgical Laser Technologies, Inc. | 1998-11-25 | Traditional | PDF ↗ |
| K983224 | XPS DRILL SYSTEM | Xomed, Inc. | 1998-10-21 | Traditional | PDF ↗ |
| K981041 | SLT BIPOLAR SHEATH | Surgical Laser Technologies, Inc. | 1998-08-27 | Traditional | PDF ↗ |
| K981637 | INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY | Linvatec Corp. | 1998-07-20 | Traditional | PDF ↗ |
| K974174 | ULTRABUR | Mednet Locator, Inc. | 1998-03-10 | Traditional | PDF ↗ |
| K972057 | POWERTREK INSTRUMENTS | Medtrek Corp. | 1997-11-05 | Traditional | PDF ↗ |
| K972584 | STRYKER HUMMER II MICRODEBRIDER SYSTEM | Stryker Endoscopy | 1997-10-01 | Traditional | PDF ↗ |
| K972865 | PROMEX ENT TISSUE REMOVAL SYSTEM | Promex, Inc. | 1997-09-29 | Traditional | PDF ↗ |
| K973286 | ENT IRRIGATING PUMP (70327700) | Gyrus Ent LLC | 1997-09-29 | Traditional | PDF ↗ |
| K972453 | XPS STRAIGHTSHOT MICRORESECTOR | Xomed, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K970965 | MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) | Midas Rex Pneumatic Tools, Inc. | 1997-04-09 | Traditional | PDF ↗ |
| K964548 | APEX UNIVERSAL DRIVE SYSTEM | Linvatec Corp. | 1997-01-17 | Traditional | PDF ↗ |
| K965080 | ANSPACH MICROMAX SYSTEM | The Anspach Effort, Inc. | 1997-01-10 | Traditional | PDF ↗ |
| K963246 | TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT | Medtronic Xomed | 1996-09-23 | Traditional | PDF ↗ |
| K962163 | MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL | Misten Medical Corp. | 1996-07-25 | Traditional | PDF ↗ |
| K961192 | IRRIGATION SYSTEM | Linvatec Corp. | 1996-04-26 | Traditional | PDF ↗ |
| K954989 | DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES | Smith & Nephew Dyonics, Inc. | 1995-11-27 | Traditional | PDF ↗ |
| K954796 | MICRO-INGRESSOR HANDIPIECE | Trebay Medical Corp. | 1995-11-06 | Traditional | PDF ↗ |
| K954715 | MICRO-PLANER HANDPIECE | Trebay Medical Corp. | 1995-10-27 | Traditional | PDF ↗ |
| K952681 | STRYKER HUMMER II MICRODEBRIDER SYSTEM | Stryker Endoscopy | 1995-07-20 | Traditional | PDF ↗ |
| K951263 | INTRAARC DRIVE SYSTEM | Linvatec Corp. | 1995-04-17 | Traditional | PDF ↗ |
| K950964 | KARL STORZ INTRA-HANDPIECES AND ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 1995-03-24 | Traditional | PDF ↗ |
| K943569 | STRYKER TOTAL PERFORMANCE SYSTEM | Stryker Corp. | 1995-01-09 | Traditional | PDF ↗ |
| K945659 | BLACKSTAR(TM) STAR SYSTEM | Xomed-Treace, Inc. | 1995-01-09 | Traditional | PDF ↗ |
| K940016 | ELECTRIC SURGICAL DRILL | Alamo City Dental Supply Co. | 1994-11-22 | Traditional | PDF ↗ |
| K945438 | EDI-BUR MICRODRILL SYSTEMS | Micromed Development Corp. | 1994-11-22 | Traditional | PDF ↗ |
| K944476 | APEX UNIVERSAL DRIVE SYSTEM | Linvatec Corp. | 1994-11-18 | Traditional | PDF ↗ |
| K943108 | MEDNEXT MICRO-DRILL | Mednext, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K940710 | STRYKER MICRODEBRIDER SYSTEM | Stryker Corp. | 1994-05-16 | Traditional | PDF ↗ |
| K914346 | DRILL MODULES MODELS 2116/2117 | Micro Surgical Instruments Corp. | 1991-11-27 | Traditional | PDF ↗ |
| K905800 | X-T AIR DRILL | Xomed-Treace, Inc. | 1991-04-22 | Traditional | PDF ↗ |
| K873154 | TREACE MAGNUM OTO-TOOL SYSTEM | Treace Medical, Inc. | 1987-09-04 | Traditional | PDF ↗ |
| K862807 | TREACE DRILL SYSTEM | Treace Medical, Inc. | 1986-08-15 | Traditional | PDF ↗ |
| K854331 | MICRO-AIRE OTO/NEURO DRILL SYSTEM | Micro-Aire Surgical Instruments, Inc. | 1986-01-21 | Traditional | PDF ↗ |
| K854332 | MICRO-AIRE STAPES DRILL SYSTEM | Micro-Aire Surgical Instruments, Inc. | 1986-01-21 | Traditional | PDF ↗ |
| K841813 | TISSUE INTEGRATED PROSTHESIS DRILL | Bofors Nobelpharma, Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K833875 | SHEA FOOTPLATE MICRODRILL | Applied Research Corp. | 1984-06-22 | Traditional | PDF ↗ |
| K833874 | SHEA MIDDLE EAR MICRODRILL | Applied Research Corp. | 1984-06-22 | Traditional | PDF ↗ |
| K831946 | SURGICAL DRILL-ELECTRIC-HANDPIECE | Entronics | 1983-11-03 | Traditional | PDF ↗ |
| K822008 | TORX OR TYPE MICRO MOTOR HANDPIECE | Kelleher Corp. | 1982-08-12 | Traditional | PDF ↗ |
| K802463 | MICRO-SURGICAL POWER INSTRUMENT SYSTEM | Spire Medical, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K792159 | FISCH DRILL SYSTEM | Jedmed Instrument Co. | 1979-11-27 | Traditional | PDF ↗ |
| K791407 | WOMED NICRO-CRAFT POWER SYSTEM | Xomed, Inc. | 1979-08-22 | Traditional | PDF ↗ |
| K781418 | XOMED TRANSSPHENOIDAL HANDPIECE | Xomed, Inc. | 1978-08-31 | Traditional | PDF ↗ |
Product code ERL · Class II · Ear, Nose, Throat. Data: openFDA.