510(k) K963246
- Device
- TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
- Applicant
- MEDTRONIC XOMED
- 510(k) number
- K963246
- Product code
- ERL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-09-23
- Date received
- 1996-08-19
- 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#
- 3014279513
- 1045254
- 9614434
- 1061124
- 1526534
- 1526611
- 3002807314
- 3010141593
- 3002806603
- 3015399803
- 3002809144
- 3005282635
- 3003678543
- 3010264076
- 3007279848
- 2020550
- 2936485
- 3010707607
- 1833986
- 3015440604
- 3010202439
- 3005820796
- 3033509898
- 3007305485
- 1057421
- 3040335671
- 3011024991
- 3016172274
- 1222928
- 3010155648
- 3011697028
- 1037007
- 3021632375
- 9610617
- 3003595343
- 3003790304
- 8030965
- 1625507
- 3004598644
- 3009420598
- 1220477
- 3030733800
- 3017210488
- 3014479313
- 1649518
- 2647346
- 8010516
- 3007997036
- 8044015
- 3011300255
- 3001239363
- 3010163695
- 3013557562
- 3010363503
- 1928237
- 1828288
- 3010375018
- 3011050570
- 9616696
- 3002807315
- 3010659131
- 1045834
- 2133641
- 9611102
- 2649614
- 3002807310
- 2648666
- 3010173425
- 3004464325
- 3008087383
- 2648623
- 3010273872
- 3008837339
- 3015453963
- 3009039068
- 1422375
- 3017521423
- 3012494290
- 3005172759
- 9681479
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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