HBLClass II

Holder, Head, Neurosurgical (Skull Clamp)

21 CFR 882.4460 / Neurology

HBL is the FDA product code for Holder, Head, Neurosurgical (Skull Clamp), a class II device type, regulated under 21 CFR 882.4460. As of 2026-09-10, FDA records hold 50 510(k) clearances under this code, the most recent dated 2025-11-06, and 14 recalls.

Classification record

Product code: HBL
Device name: Holder, Head, Neurosurgical (Skull Clamp)
Regulation: 21 CFR 882.4460
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 50
Ingested recalls: 14

Clearances, product code HBL

By decision year

50 clearances under product code HBL with a decision year between 1982 and 2025, 1991 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code HBL by decision year
Year	Clearances
1982	1
1988	1
1989	1
1990	1
1991	5
1993	3
1994	1
1995	1
1996	2
2000	3
2002	1
2003	2
2005	3
2007	3
2008	2
2009	3
2010	1
2011	1
2012	2
2013	2
2014	2
2017	1
2019	2
2020	2
2021	1
2024	2
2025	1

Applicants with the most clearances

Product code HBL

Applicants holding the most 510(k) clearances under product code HBL
Applicant	Clearances
Integra LifeSciences Corporation	10
Black Forest Medical GmbH	9
Ohio Medical Instrument Co., Inc.	7
Cerenovus, Inc.	5
Dinkler Surgical Devices, Inc.	2
Brainlab, Inc.	1
Downs Surgical, Ltd.	1
Engineered Orthopedic Technologies, Inc.	1
Image-Guided Neurologics, Inc.	1
Imris, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order