Cleared Traditional

K231580 - NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (FDA 510(k) Clearance)

K231580 · Medtronic Xomed, Inc. · Ear, Nose, Throat device

Aug 2023

Decision

91d

Days

Class 2

Risk

K231580 is an FDA 510(k) clearance for the NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35). 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 August 30, 2023, 91 days after receiving the submission on May 31, 2023.

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

Submission Details

510(k) Number	K231580 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 31, 2023
Decision Date	August 30, 2023
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF