510(k) K241045
- Device
- Disposable Subdermal Needle Electrode, Corkscrew
- Applicant
- Technomed Europe
- 510(k) number
- K241045
- Product code
- GXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-11
- Date received
- 2024-04-17
- Regulation
- 882.1350
- Classification name
- Electrode, Needle
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sanne Habets
- Address
- Amerikalaan 71 Maastricht-Airport NL 6199 AE 6199 AE
FDA Registration Numbers#
- 1018470
- 3017636737
- 3003120897
- 3004464325
- 1000632857
- 3005581220
- 3010173425
- 3019878714
- 2024024
- 3017210488
- 3014479313
- 1056553
- 3004040397
- 1220477
- 3014656749
- 3010220595
- 3030733800
- 1063285
- 3003477135
- 3010611950
- 2246552
- 3007766601
- 2025694
- 1030489
- 9610691
- 3010805941
- 3013298431
- 3009417901
- 3011577940
- 3005581270
- 1219619
- 9710582
- 1067162
- 3008892509
- 3009039068
- 3010370554
- 2183946
- 3008588921
- 2953359
- 3006849754
- 3010039400
- 3013162291
- 3005941719
- 3007221462
- 9612501
- 3018094310
- 1047843
- 3006697681
- 1319660
- 1048735
- 2022388
- 3011137372
- 3012494290
- 3015859709
- 3013557562
- 3009171251
- 1045254
- 3008806011
- 3007770159
- 1526534
- 2027467
- 3003851073
- 9710376
- 3008617703
Source Documents#
Other 510(k) Records For Product Code GXZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232581 | Medical Disposable Sterile Needle Electrode | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-04 |
| K231691 | Phantom XL Insulated Dilators | TeDan Surgical Innovations, Inc. | 2023-06-29 |
| K200984 | Guardian Needle Electrode | Rhythmlink International, LLC | 2020-05-27 |
| K192603 | Spes Medica Subdermal Needle Electrodes | Spes Medica Srl | 2019-11-22 |
| K190801 | PressOn Electrode Headset | Rhythmlink International, LLC | 2019-07-10 |
| K161566 | DMS Disposable Subdermal Needle Electrodes | Daehan Medical Systems Co., Ltd. | 2016-12-21 |
| K142470 | E-Shield Multi-paried Subdermal Needle Electrodes | Neuroinvent, Inc. | 2014-11-05 |
| K140200 | E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES | Neuroinvent, Inc. | 2014-07-18 |
| K130220 | MR CONDITIONAL PRESSON ELECTRODE | Rhythmlink International, LLC | 2013-07-22 |
| K130136 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, | Technomed Europe | 2013-07-19 |
| K121347 | PRESSON ELECTRODE | Rhythmlink International, LLC | 2012-07-12 |
| K103103 | PRESSON ELECTRODE | Persyst Development Corp. | 2011-12-08 |
| K110419 | AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS | Stryker Spine | 2011-07-28 |
| K100912 | DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE | Kirwan Surgical Products, Inc. | 2010-08-19 |
| K073229 | NERVE MONITORING CABLE | Pioneer Surgical Technology | 2008-06-06 |