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510(k) K253580

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) by Tedan Surgical Innovations — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2026
Date Received
November 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Nerve Locator
Device Class
Class II
Regulation Number
874.1820
Review Panel
NE
Submission Type

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

Other clearances by Tedan Surgical Innovations

  • K231691 — Phantom XL Insulated Dilators (June 29, 2023)
  • K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological (March 20, 2017)
  • K140088 — PHANTOM XL INSULATED DILATORS (September 25, 2014)

Other clearances for product code PDQ

  • K243636 — Neuralytix iD3 System (NTX-9001) (June 26, 2025)
  • K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications (February 10, 2023)
  • K221821 — ATEC IOM Accessory Instruments (September 23, 2022)
  • K220160 — PediGuard Threaded (March 31, 2022)
  • K203684 — Neurosign V4 Intraoperative Nerve Monitor (March 17, 2021)
  • K201454 — DSG Connect Technology (February 10, 2021)
  • K191723 — ATEC IOM Accessory Instruments (October 18, 2019)
  • K190163 — ALARA Neuro Access Kit (July 16, 2019)
  • K182617 — ATEC IOM Accessory Instruments (May 9, 2019)
  • K182662 — NAV PAK Needle, NIM NAV PAK Needle (April 10, 2019)