510(k) K182542
- Device
- The EPAD 2 System
- Applicant
- SafeOp Surgical, Inc.
- 510(k) number
- K182542
- Product code
- GWF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-02-22
- Date received
- 2018-09-17
- Regulation
- 882.1870
- Classification name
- Stimulator, Electrical, Evoked Response
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Richard O'Brien
- Address
- 11350 Mccormick Rd., Suite 1003 Hunt Valley MD US 21031 21031
FDA Registration Numbers#
- 2024311
- 9611896
- 3006128100
- 1056553
- 3010041499
- 3013501110
- 3003631667
- 2133772
- 2183456
- 8043933
- 3018708317
- 3003080184
- 3010047454
- 1047843
- 3018094310
- 3009973505
- 1048735
- 9615126
- 3030154814
- 3012352782
- 3007713076
- 3007770159
- 2530126
- 3003851073
- 3007014520
- 2031966
- 3017636737
- 3009144915
- 1824199
- 3006783837
- 3017448360
- 3000279201
- 3012263546
- 3007611554
- 2183946
- 1119189
- 3003935342
- 3016852448
- 3006418479
- 3006639944
- 3008773490
- 3016438694
- 3023852420
- 1045254
- 3010209365
- 1526534
- 3004753785
- 2023374
- 9612330
- 3005545216
- 3019878714
- 3009050824
- 3012182497
- 1030489
- 9612389
- 3005581270
- 3007962724
- 8021774
- 3005706667
- 9611252
- 9612501
- 1052723
- 2031093
- 3007147067
- 3030412764
- 2032098
- 2027467
- 9613619
- 3003120897
- 2080783
- 1835251
- 3009973336
- 3009959868
- 1221763
- 3024996452
- 3010611950
- 3043543260
- 1650946
- 3001239363
Source Documents#
Other 510(k) Records For Product Code GWF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252842 | SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | 2026-01-11 |
| K243982 | Nicolet EDX | Natus Neurology Incorporated | 2025-01-22 |
| K243495 | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | 2024-12-12 |
| K242345 | Delphi Stimulator | Quantalx Neuroscience | 2024-11-05 |
| K234092 | SafeOp 3: Neural Informatix Systeem | Alphatec Spine, Inc. | 2024-04-19 |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | Soterix Medical, Inc. | 2024-03-25 |
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2023-10-27 |
| K230415 | Cadwell Guardian | Cadwell Industries, Inc. | 2023-08-17 |
| K213849 | SafeOp 2: Neural Informatix System | Alphatec Spine, Inc. | 2022-03-09 |
| K212166 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Inomed Medizintechnik GmbH | 2022-01-07 |
| K192823 | MEGA-TMS | Soterix Medical, Inc. | 2021-08-13 |
| K190703 | Neuro-IOM system with Neuro-IOM.NET software | Neurosoft , Ltd. | 2021-05-22 |
| K200759 | NIM Vital, Nerve Integrity Monitor | Medtronic Xomed, Inc. | 2020-10-28 |
| K170677 | Neurovision Nerve Locator Monitor (Nerveana), EMGView Software | Neurovision Medical Product, Inc. | 2017-04-05 |
| K162873 | MEP Monitor | Tonica Elektronik A/S | 2017-03-31 |
Legacy Summary#
summary