Phantom XL Insulated Dilators— 510(k) K231691

Name: FDA 510(k) clearance K231691
Creator: U.S. Food and Drug Administration
Published: 2023-06-29

Substantially Equivalent

TeDan Surgical Innovations, Inc.

FDA 510(k) clearance K231691 for Phantom XL Insulated Dilators, Substantially Equivalent on 2023-06-29. Applicant: TeDan Surgical Innovations, Inc.. Device class: 2.

Clearance details

Applicant: TeDan Surgical Innovations, Inc.
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 2023-06-09
Decision date: 2023-06-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXZ

view all

K241045 — Disposable Subdermal Needle Electrode, Corkscrew2024-12-11
K232581 — Medical Disposable Sterile Needle Electrode2023-12-04
K200984 — Guardian Needle Electrode2020-05-27
K192603 — Spes Medica Subdermal Needle Electrodes2019-11-22
K190801 — PressOn Electrode Headset2019-07-10

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