Cleared Traditional

K994344 - NEUROTHERM RF CANNULA
(FDA 510(k) Clearance)

K994344 · Rocket Medical Plc · Neurology

Mar 2000

Decision

90d

Days

Class 2

Risk

K994344 is an FDA 510(k) clearance for the NEUROTHERM RF CANNULA. This device is classified as a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI).

Submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on March 21, 2000, 90 days after receiving the submission on December 22, 1999.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4725.

Submission Details

510(k) Number	K994344 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 1999
Decision Date	March 21, 2000
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF