STRYKER DISPOSABLE CRANIAL PERFORATOR BIT— 510(k) K082010

Clearance details

Applicant

Stryker Ireland Ltd., Instruments Division

Product code

Code HBF

Device class

Class 2

Regulation

21 CFR 882.4305

Advisory panel

Neurology

Date received

2008-07-15

Decision date

2008-12-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carrigtwohill, Co.Cork, IE

• K254177 — Disposable Sterile Skull Drill (LZ)2026-09-11
• K231403 — evoDrill Cranial Perforator2024-03-06
• K213228 — NeuroLine Disposable Cranial Perforator with Hudson end2022-06-20
• K183581 — Codman Disposable Perforators2019-01-20
• K141455 — EASYDRILL AUTOSTOP CRANIAL PERFORATOR2015-03-16

• K073633 — STRYKER ESSX MICRODEBRIDER SYSTEM2008-08-26

Injury

587

Malfunction

621

Other

1

Total

1,209

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0431-2021 — Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001Class II·Terminated·Stryker Instruments Div. of Stryker Corporation·20201016

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082010.