Cleared Special

Phantom XL Insulated Dilators

K231691 · TeDan Surgical Innovations, Inc. · Neurology

Jun 2023

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K231691 is an FDA 510(k) clearance for the Phantom XL Insulated Dilators, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by TeDan Surgical Innovations, Inc. (Sugar Land, US). The FDA issued a Cleared decision on June 29, 2023, 20 days after receiving the submission on June 9, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number	K231691 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2023
Decision Date	June 29, 2023
Days to Decision	20 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF