Cleared Traditional

pNOVUS 21 Microcatheter

K242420 · Phenox, Ltd. · Neurology

Nov 2024

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K242420 is an FDA 510(k) clearance for the pNOVUS 21 Microcatheter, a Catheter, Intravascular, Diagnostic (Class II — Special Controls, product code DQO), submitted by Phenox, Ltd. (Galway, IE). The FDA issued a Cleared decision on November 12, 2024, 89 days after receiving the submission on August 15, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number	K242420 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 2024
Decision Date	November 12, 2024
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF