Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)— 510(k) K253580
Substantially EquivalentTedan Surgical Innovations
FDA 510(k) clearance K253580 for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S), Substantially Equivalent on 2026-04-26. Applicant: Tedan Surgical Innovations. Device class: 2.
Summary
Tedan Surgical Innovations' record names two dilator listings: Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S) and Sterile, Insulated Dilator, 20mm (MDT-0469S). Both are filed under product code PDQ (Neurosurgical Nerve Locator).
Class II, 21 CFR 874.1820. The record lists Ear, Nose, and Throat as the classification panel, but the Neurology review panel handled this Traditional 510(k).
Tedan Surgical Innovations filed from Sugar Land, Texas. Review took 160 calendar days (November 17, 2025 to April 26, 2026).
Clearance details
- Applicant
- Tedan Surgical Innovations
- Product code
- Product code PDQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sugar Land, TX, US
Recent devices under product code PDQ
view all- K260992 — iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)
- K243636 — Neuralytix iD3 System (NTX-9001)
- K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications
- K221821 — ATEC IOM Accessory Instruments
- K220160 — PediGuard Threaded
Data sourced from openFDA. This site is unofficial and independent of the FDA.