PHANTOM XL INSULATED DILATORS— 510(k) K140088

Name: FDA 510(k) clearance K140088
Creator: U.S. Food and Drug Administration
Published: 2014-09-25

Substantially Equivalent

Tedan Surgical Innovations, LLC

FDA 510(k) clearance K140088 for PHANTOM XL INSULATED DILATORS, Substantially Equivalent on 2014-09-25. Applicant: Tedan Surgical Innovations, LLC. Device class: 2.

Clearance details

Applicant: Tedan Surgical Innovations, LLC
Product code: Code PDQ
Device class: Class 2
Regulation: 21 CFR 874.1820
Advisory panel: Ear, Nose, Throat
Date received: 2014-01-14
Decision date: 2014-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

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)2026-06-25
K253580 — Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)2026-04-26
K243636 — Neuralytix iD3 System (NTX-9001)2025-06-26
K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications2023-02-10
K221821 — ATEC IOM Accessory Instruments2022-09-23

More clearances from Tedan Surgical Innovations, LLC

view all

K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems2017-03-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.