Dilator Tube Set
FDA 510(k) K120590 · Koros USA, Inc.
510(k) numberK120590
Submission
- Device name
- Dilator Tube Set
- Applicant
- Koros USA, Inc.
Moorepark, CA, US - Received
- February 28, 2012
- Decision date
- May 7, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PDQ – Neurosurgical Nerve Locator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1820
- Specialty
- Ear, Nose, Throat
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Other 510(k)s with product code PDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball…PDQ · Traditional | Neuralytix | 06/25/2026SE |
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm…PDQ · Traditional | Tedan Surgical Innovations | 04/26/2026SE |
| K243636 | Neuralytix iD3 System (NTX-9001)PDQ · Traditional | Neuralytix, LLC | 06/26/2025SE |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation IndicationsPDQ · Traditional | Medos International SARL | 02/10/2023SE |
| K221821 | ATEC IOM Accessory InstrumentsPDQ · Traditional | Alphatec Spine, Inc. | 09/23/2022SE |
| K220160 | PediGuard ThreadedPDQ · Traditional | Spineguard S.A. | 03/31/2022SE |
| K203684 | Neurosign V4 Intraoperative Nerve MonitorPDQ · Traditional | Magstim Company, Ltd. | 03/17/2021SE |
| K201454 | DSG Connect TechnologyPDQ · Traditional | Spineguard S.A. | 02/10/2021SE |
| K191723 | ATEC IOM Accessory InstrumentsPDQ · Traditional | Alphatec Spine, Inc. | 10/18/2019SE |
| K190163 | ALARA Neuro Access KitPDQ · Traditional | SurGenTec, LLC | 07/16/2019SE |
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Questions and answers
When was Dilator Tube Set cleared by the FDA?
Dilator Tube Set (K120590) received a 510(k) decision of Substantially Equivalent on May 7, 2013, 434 days after the submission was received.
What is the product code of K120590?
The FDA product code is PDQ – Neurosurgical Nerve Locator, a Class II (moderate risk) device regulated under 21 CFR 874.1820.