Cleared Traditional

hekaDrill

K193630 · Zethon, Ltd. · Neurology

Apr 2021

Decision

470d

Days

Class 2

Risk

About This 510(k) Submission

K193630 is an FDA 510(k) clearance for the hekaDrill, a Motor, Drill, Electric (Class II — Special Controls, product code HBC), submitted by Zethon, Ltd. (Aston Clinton, GB). The FDA issued a Cleared decision on April 9, 2021, 470 days after receiving the submission on December 26, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number	K193630 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2019
Decision Date	April 09, 2021
Days to Decision	470 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF