510(k) K983224
- Device
- XPS DRILL SYSTEM
- Applicant
- XOMED, INC.
- 510(k) number
- K983224
- Product code
- ERL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-10-21
- Date received
- 1998-09-14
- 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
- DAVID TIMLIN
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers#
- 3008812560
- 3005820796
- 2020550
- 9611102
- 3001239363
- 3008868758
- 3014279513
- 2936485
- 1833986
- 3025764223
- 3027339887
- 3036756245
- 1045834
- 2133641
- 3000126629
- 3030733800
- 1017294
- 3005333358
- 1037007
- 3033536319
- 3010141593
- 3025603301
- 1048735
- 3011300255
- 3016172274
- 3010375018
- 3002808022
- 3002807314
- 3010163695
- 3018094310
- 8010516
- 1222928
- 1649518
- 3010659131
- 3015882686
- 1226544
- 9614434
- 3005172759
- 3010173425
- 2650143
- 9611253
- 1018470
- 3008253300
- 3007279848
- 3004774118
- 1220477
- 3004464325
- 3015453963
- 2647346
- 3010264076
- 1045254
- 2183744
- 3010363503
- 3003800209
- 1928237
- 3003933619
- 3008087383
- 3001592626
- 1057421
- 2649614
- 3014479313
- 3007997036
- 1926681
- 3033509898
- 3012494290
- 3011543740
- 3015967359
- 3015399803
- 1834331
- 3010707607
- 8044015
- 2953359
- 3006891611
- 3011024991
- 3005282635
- 2133786
- 3017521423
- 3010972758
- 2648623
- 1625507
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
FDA Review#
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