FDA.reportPublic FDA data

510(k) K231403

Device
evoDrill Cranial Perforator
Applicant
Evonos GmbH & Co. KG
510(k) number
K231403
Product code
HBF
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-06
Date received
2023-05-15
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
Jörg Mans
Address
Stockacher Strasse 134 Tuttingen DE 78532 78532

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
K213228NeuroLine Disposable Cranial Perforator with Hudson endEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.2022-06-20
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