510(k) K150728
- Device
- XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
- Applicant
- MEDTRONIC XOMED, INC.
- 510(k) number
- K150728
- Product code
- ERL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-14
- Date received
- 2015-03-20
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Gabriela Anchonda
- Address
- 6743 Southpoint Dr. N. Jacksonville FL US 32216 32216
FDA Registration Numbers
- 3010972758
- 3010264076
- 2650143
- 1061124
- 3002807315
- 2133786
- 3007456622
- 3001592626
- 3004464325
- 3001239363
- 3015453963
- 2183744
- 3009039068
- 3003933619
- 1834331
- 1018470
- 3015212339
- 3004598644
- 3011024991
- 8044015
- 9681479
- 3025603301
- 3003595343
- 2649614
- 3010163695
- 1045834
- 3011050570
- 3034676720
- 3013557562
- 3010202439
- 3015882686
- 3017521423
- 3003678543
- 1625507
- 3017210488
- 3002807314
- 1045254
- 8010177
- 3005382983
- 3003800209
- 3007305485
- 3016172274
- 3008087383
- 3027339887
- 3002808022
- 3014279513
- 9680741
- 1649518
- 3005820796
- 1058584
- 2953359
- 3015173212
- 1526611
- 1057421
- 3005282635
- 3002807310
- 2936485
- 3009417901
- 1928237
- 3014342096
- 1526534
- 1319639
- 1828288
- 3008812560
- 2133641
- 3006891611
- 9611102
- 2647346
- 2648623
- 3021632375
- 3007997036
- 3040335671
- 3005172759
- 3011697028
- 9611253
- 3000126629
- 3010141593
- 3012494290
- 3010659131
- 8030965
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000915469 | N/A | MEDTRONIC XOMED, INC. | 2025-06-23 |
| 00763000915452 | XPS Nexus | MEDTRONIC XOMED, INC. | 2025-06-23 |
| 00763000299217 | Indigo | MEDTRONIC XOMED, INC. | 2020-10-03 |
| 00763000172091 | Indigo™ | MEDTRONIC XOMED, INC. | 2019-05-02 |
| 00763000007454 | XPS Nexus™ | MEDTRONIC XOMED, INC. | 2018-08-19 |
| 00763000007461 | XPS Nexus™ | MEDTRONIC XOMED, INC. | 2018-05-31 |
| 00643169789609 | Indigo™ | MEDTRONIC XOMED, INC. | 2017-04-16 |
| 00613994933676 | Indigo™ | MEDTRONIC XOMED, INC. | 2016-06-19 |
| 00643169434141 | XPS Nexus™ | MEDTRONIC XOMED, INC. | 2016-05-05 |
| 00643169434134 | XPS Nexus™ | MEDTRONIC XOMED, INC. | 2016-05-05 |
Legacy Summary
summary