Cleared Traditional

evoDrill Cranial Perforator

K231403 · Evonos GmbH & Co. KG · Neurology

Mar 2024

Decision

296d

Days

Class 2

Risk

About This 510(k) Submission

K231403 is an FDA 510(k) clearance for the evoDrill Cranial Perforator, a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II — Special Controls, product code HBF), submitted by Evonos GmbH & Co. KG (Tuttingen, DE). The FDA issued a Cleared decision on March 6, 2024, 296 days after receiving the submission on May 15, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4305.

Submission Details

510(k) Number	K231403 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2023
Decision Date	March 06, 2024
Days to Decision	296 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF