NeuroLine Disposable Cranial Perforator with Hudson end

Q: What is the product code of K213228?

The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.

FDA 510(k) K213228 · Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.

Substantially Equivalent

510(k) numberK213228

Submission

Device name: NeuroLine Disposable Cranial Perforator with Hudson end
Applicant: Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
Debrecen, HU
Received: September 29, 2021
Decision date: June 20, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4305
Specialty: Neurology

Other 510(k)s with product code HBF

510(k)	Device	Applicant	Decision
K254177	Disposable Sterile Skull Drill (LZ)HBF · Traditional	Guizhou Zirui Technology Co., Ltd.	09/11/2026SE
K231403	evoDrill Cranial PerforatorHBF · Traditional	Evonos GmbH & Co. KG	03/06/2024SE
K183581	Codman Disposable PerforatorsHBF · Special	Integra Lifesciences Corp.	01/20/2019SE
K141455	Easydrill Autostop Cranial PerforatorHBF · Traditional	Micromar Ind. Com. , Ltd.	03/16/2015SE
K121253	Meridian Cranial PerforatorHBF · Traditional	Adeor Medical Technologies GmbH	07/17/2012SE
K082010	Stryker Disposable Cranial Perforator BitHBF · Traditional	Stryker Ireland Ltd., Instruments Division	12/29/2008SE
K082637	Cranial PerforatorHBF · Traditional	The Anspach Effort, Inc.	12/22/2008SE
K073336	Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231HBF · Special	Codman & Shurtleff, Inc.	01/04/2008SE
K071931	Codman Disposable Perforator, Model(S) 26-1222, 26-1223HBF · Traditional	Codman & Shurtleff, Inc.	10/22/2007SE
K032970	Acra-Cut Xpress 120HBF · Traditional	Acra Cut, Inc.	12/08/2003SE

Questions and answers

When was NeuroLine Disposable Cranial Perforator with Hudson end cleared by the FDA?

NeuroLine Disposable Cranial Perforator with Hudson end (K213228) received a 510(k) decision of Substantially Equivalent on June 20, 2022, 264 days after the submission was received.

What is the product code of K213228?

The FDA product code is HBF – Drills, Burrs, Trephines & Accessories (Compound, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4305.