Cleared Traditional

hekaDrill

K233958 · Zethon, Ltd. · Ear, Nose, Throat

Mar 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K233958 is an FDA 510(k) clearance for the hekaDrill, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Zethon, Ltd. (Aston Clinton, GB). The FDA issued a Cleared decision on March 14, 2024, 90 days after receiving the submission on December 15, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K233958 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2023
Decision Date	March 14, 2024
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4250