FDA.reportPublic FDA data

510(k) K213228

Device
NeuroLine Disposable Cranial Perforator with Hudson end
Applicant
Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
510(k) number
K213228
Product code
HBF
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-20
Date received
2021-09-29
Regulation
882.4305
Classification name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gyula Ujvari
Address
Bartok Bela U. 113/B Debrecen HU 4031 4031

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HBF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231403evoDrill Cranial PerforatorEvonos GmbH & Co. KG2024-03-06
K183581Codman Disposable PerforatorsIntegra Lifesciences Corp.2019-01-20
K141455EASYDRILL AUTOSTOP CRANIAL PERFORATORMicromar Ind. Com. , Ltd.2015-03-16
K121253MERIDIAN CRANIAL PERFORATORAdeor Medical Technologies GmbH2012-07-17
K082010STRYKER DISPOSABLE CRANIAL PERFORATOR BITStryker Ireland Ltd., Instruments Division2008-12-29
K082637CRANIAL PERFORATORThe Anspach Effort, Inc.2008-12-22
K073336CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231Codman & Shurtleff, Inc.2008-01-04
K071931CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223Codman & Shurtleff, Inc.2007-10-22
K032970ACRA-CUT XPRESS 120Acra Cut, Inc.2003-12-08
K982991ANSPACH ACCESS CRANIAL PERFORATORThe Anspach Effort, Inc.1998-10-21
K933894DISPOSABLE PERFORATORCodman & Shurtleff, Inc.1993-12-10
K924242DISPOSABLE PERFORATORCodman & Shurtleff, Inc.1993-07-08
K892866AUTOMATIC CRANIAL DRILL (PERFORATOR)Acra Cut, Inc.1989-06-15
K875019GHAJAR GUIDE SYSTEM FOR THE PERFORATORNeurodynamics, Inc.1988-01-22
K833266ACRA-CUTAcra Cut, Inc.1983-12-29