510(k) K253580
- Device
- Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
- Applicant
- Tedan Surgical Innovations
- 510(k) number
- K253580
- Product code
- PDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-26
- Date received
- 2025-11-17
- Regulation
- 874.1820
- Classification name
- Neurosurgical Nerve Locator
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Arya Monticino-Larsen
- Address
- 12320 Cardinal Meadow Dr. Suite 150 Sugar Land TX US 77478 77478
FDA Registration Numbers#
- 1219114
- 3007014520
- 2031966
- 1221485
- 3009144915
- 2027062
- 3004464325
- 3019878714
- 3006128100
- 3009959868
- 1526439
- 1221763
- 3004024955
- 1056553
- 3004519921
- 1220477
- 3010057495
- 1211566
- 3008102049
- 3009050824
- 3006783837
- 2246552
- 1218017
- 3023164
- 3043543260
- 3012182497
- 2133772
- 3012263546
- 3005726885
- 3003080184
- 3021948057
- 3003935342
- 3012495575
- 3005706667
- 3010047454
- 8021774
- 3008114965
- 3004598644
- 2030624
- 1047843
- 3006418479
- 3010123206
- 3042364673
- 3006639944
- 3009973505
- 1319660
- 3024673
- 3007156625
- 1319639
- 3016438694
- 3023852420
- 3007700286
- 3020018
- 3008868758
- 3007713076
- 3030412764
- 1928237
- 2027467
Source Documents#
Other 510(k) Records For Product Code PDQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243636 | Neuralytix iD3 System (NTX-9001) | Neuralytix, LLC | 2025-06-26 |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | 2023-02-10 |
| K221821 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2022-09-23 |
| K220160 | PediGuard Threaded | Spineguard S.A. | 2022-03-31 |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2021-03-17 |
| K201454 | DSG Connect Technology | Spineguard S.A. | 2021-02-10 |
| K191723 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019-10-18 |
| K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | 2019-07-16 |
| K182617 | ATEC IOM Accessory Instruments | Alphatec Spine, Inc. | 2019-05-09 |
| K182662 | NAV PAK Needle, NIM NAV PAK Needle | Boston Endo Surgical Tech, | 2019-04-10 |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | Magstim Company, Ltd. | 2018-11-09 |
| K180542 | NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe | Boston Endo Surgical Tech, | 2018-08-22 |
| K173526 | SENTIO MMG Gen 2 | Medos International SARL | 2018-04-05 |
| K173134 | SENTIO MMG Pedicle Access Needles | Medos International SARL | 2018-03-22 |
| K171807 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2017-07-18 |