Cleared Traditional

K213246 - NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long (FDA 510(k) Clearance)

K213246 · Medtronic Xomed, Inc. · Ear, Nose, Throat device

Mar 2022

Decision

172d

Days

Class 2

Risk

K213246 is an FDA 510(k) clearance for the NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long. This device is classified as a Stimulator, Nerve (Class II - Special Controls, product code ETN).

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 21, 2022, 172 days after receiving the submission on September 30, 2021.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number	K213246 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 30, 2021
Decision Date	March 21, 2022
Days to Decision	172 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF