Cleared Traditional

NeuroLine Disposable Cranial Perforator with Hudson end

K213228 · Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. · Neurology

Jun 2022

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K213228 is an FDA 510(k) clearance for the NeuroLine Disposable Cranial Perforator with Hudson end, a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II — Special Controls, product code HBF), submitted by Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. (Debrecen, HU). The FDA issued a Cleared decision on June 20, 2022, 264 days after receiving the submission on September 29, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4305.

Submission Details

510(k) Number	K213228 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2021
Decision Date	June 20, 2022
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF