510(k) K081277
- Device
- XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
- Applicant
- MEDTRONIC XOMED, INC.
- 510(k) number
- K081277
- Product code
- ERL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-09-05
- Date received
- 2008-05-05
- Regulation
- 874.4250
- Classification name
- Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANTOINE KOUCHAKJY
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers#
- 3003678543
- 2649614
- 9610617
- 3025764223
- 3015967359
- 1526711
- 1222928
- 3005382983
- 1061124
- 3000126629
- 3003595343
- 3010972758
- 3015212339
- 9616696
- 3008868758
- 3001592626
- 3009420598
- 9612501
- 3015173212
- 3004111573
- 3003933619
- 3015453963
- 3010155648
- 1045834
- 1226544
- 3011543740
- 3010141593
- 3010163695
- 3012607373
- 2648666
- 3010707607
- 8044015
- 3008087383
- 2183744
- 3040335671
- 2133641
- 3010375018
- 8043792
- 3007279848
- 2133786
- 1625507
- 3009039068
- 9680741
- 3007456622
- 1833986
- 1928237
- 3002807315
- 3002807310
- 3011300255
- 3003800209
- 3004598644
- 1319639
- 3011050570
- 1018470
- 8010155
- 3010273872
- 3007997036
- 3006891611
- 3010659131
- 1057421
- 3033509898
- 3003418325
- 3002806603
- 8010177
- 3003790304
- 3030733800
- 3004774118
- 3005282635
- 1058584
- 1526611
- 3013557562
- 2648623
- 3011024991
- 3005333358
- 3010202439
- 1649518
- 1037007
- 3002807314
- 3002809144
- 3012336822
Source Documents#
Other 510(k) Records For Product Code ERL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K233958 | hekaDrill | Zethon, Ltd. | 2024-03-14 |
| K221184 | ORiGO System | Bien-Air Surgery SA | 2022-11-02 |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | 2022-05-26 |
| K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | 2022-01-19 |
| 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 |
| 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 |
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand | Interscope, Inc. | 2019-12-13 |
| K180063 | OCM-G1 Attachment | The Anspach Effort, Inc. | 2018-03-27 |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 Console | Stryker Corporation | 2017-09-15 |
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | Laurimed, LLC | 2017-03-09 |
| K161376 | DragonFly Surgical Drill System | Grace Medical, Inc. | 2016-08-25 |
| K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) | Laurimed, LLC | 2016-06-22 |
| K152744 | DIEGO ELITE DRILL | Gyrus Acmi, Inc. | 2016-06-10 |
| 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 |
Legacy Summary#
summary