Search Results
Found 11 results
510(k) Data Aggregation
K Number
K231403Device Name
evoDrill Cranial Perforator
Manufacturer
Evonos GmbH & Co. KG
Date Cleared
2024-03-06
(296 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Product Code :
HBF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm.
Device Description
The evonos evoDrill cranial perforator are single-use for trephining the cranial bone. The perforators have an automatic stop mechanism that stops the trephination process as soon as the skull bone has been pierced. The two variants evoDrill cranial perforator 3-flutes and evoDrill cranial perforator 4-flutes are available in two versions that are suitable for different bone thicknesses.
The first version is used from bone thicknesses of 3mm, the second version is used for trepanation with bone thicknesses between 1mm and 3mm. Both variants are available in four different diameters.
The evonos evoDrill cranial perforator per CFR, Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr holes through the skull of a patient. The evonos evoDrill cranial perforator are devices similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra Cut Automatic Cranial Drill DGR-1 #200-241; DGR-II #200-251 and Codman Disposable Perforators 26-1222, 26-1223). The evonos evoDrill cranial perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 RPM to 1500 RPM.
Ask a Question
K Number
K213228Device Name
NeuroLine Disposable Cranial Perforator with Hudson end
Manufacturer
EMD Endoszkop Muszer Gyarto es Kereskedelmi Kft.
Date Cleared
2022-06-20
(264 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Product Code :
HBF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NeuroLine perforators are designed to make holes in the skull bone. The perforators have an integrated safety mechanism that releases automatically after passing through the bone and stops drilling.
Device Description
The NeuroLine Disposable Cranial perforators (NLO-x/y-z) are single-use cutting devices that are packaged sterile and are used to perforate the skull bone. The perforator functions automatically, which means that it employs a clutch mechanism to automatically disenqage once perforation is accomplished and as the drill ceases to find resistance to bone.
The perforator has Hudson type connection and can connect to all the driver units with Hudson connection.
Perforators are offered in three different sizes: 6/9 mm, 7/13 mm and 11/14 mm. Sizes indicate hole diameters to be made by perforators in millimeters.
Perforators are also differentiated based on the thickness of skull bone. The NLO-x/y-3.0 perforators are used on skulls at least 3 mm thick, whereas NLO-x/y-1.5 ones are used on skulls at least 1.5 mm thick.
Ask a Question
K Number
K183581Device Name
Codman Disposable Perforators
Manufacturer
Integra LifeSciences Corp.
Date Cleared
2019-01-20
(30 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Product Code :
HBF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Codman Disposable Perforator is for use in perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.
Device Description
The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. When properly used, the Disposable Perforators are designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point. They are designed with a Hudson end and are available in three color-coded sizes:
- 14mm (blue ABS sleeve) – product number: 26-1221
- 11mm (green ABS sleeve) product number: 26-1222 ●
- 9mm (yellow ABS sleeve) product number: 26-1223 ●
Ask a Question
K Number
K141455Device Name
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
Manufacturer
MICROMAR IND. COM. LTD.
Date Cleared
2015-03-16
(287 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Product Code :
HBF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EasyDrill Autostop Cranial Perforator is a sterile, single use cutting device intended for performing cranial bone trephination.
Device Description
The EasyDrill Autostop Cranial Perforator comprises of an Inner and Outer Drill, and a Hudson Shank that is designed to lock onto a Pneumatic or an Electric Drill Motors.
The EasyDrill Autostop Cranial Perforator device is a bone cutting and drilling instrument used in conjunction with a surgical motor and a Hudson Chuck - speed reducer attachment, to drill access holes through a patient's skull. When properly used, the EasyDrill Autostop Cranial Perforator employs a clutch mechanism to automatically disengage once perforation is accomplished and as the drill ceases to find resistance to bone.
The EasyDrill Autostop Cranial Perforator is a mechanically powered tool, designed to create an access hole through the skull. The subject Perforator device derives its mechanical torque and rotational speed from various legally marketed Electric and/or Pneumatic Drill Motors. The EasyDrill Autostop Cranial Perforator device is latched onto a Hudson Chuck device, which is in turn attached to the Drill Motors.
The EasyDrill Autostop Cranial Perforator is provided Gamma Sterilized, in a sealed packaging and is designed for single patient use only.
Ask a Question
K Number
K121253Device Name
MERIDIAN CRANIAL PERFORATOR
Manufacturer
ADEOR MEDICAL TECHNOLOGIES GMBH
Date Cleared
2012-07-17
(83 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Product Code :
HBF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The adeor® Meridian™ Cranial Perforator is a sterile, single-use cutting accessory intended for cranial burr-hole trephination in neurological surgery.
The Meridian™ Perforator is a single-use surgical device for cranium perforation. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforator version automatically releases and stops perforating at cranial bone thickness of at least 1.5 mm.
The perforators are available in three sizes: for burr-hole diameters of 6 mm, 7 mm and 11 mm.
Device Description
The Meridian™ Cranial Perforator is a sterile packed, single-use cutting device intended to perform cranial burr-hole trephination in neurosurgery, driven by powered sources having a standardized and commonly used Hudson fitting clutch. The device automatically releases and stops perforating at cranial bone thickness of at least 3 mm. The Meridian™ pediatric perforators automatically release and stop perforating at cranial bone thickness of at least 1.5 mm. Both versions are available for burr-hole diameters of Ø6. Ø7 and Ø11 mm.
The Meridian™ Cranial Perforator per CFR. Part 882.4305, is a bone cutting and drilling instrument driven by a pneumatic or electric surgical motor in order to drill burr-holes through the skull of a patient. An integrated clutch mechanism prevents plunging of the perforator tip into the underlying dura and parenchyma tissue. The device is a Class II (USA) device and classified IIa in Europe (EEC).
The Meridian™ Cranial Perforator is a device similar in design and construction to other cranial perforators currently on the market; (e.g.: Acra-Cut models DGR-II and Codman Disposable Perforators etc ... )
The Meridian™ Cranial Perforator requires a motor and an attached or integrated speed reducer in order to run the perforators at a speed range of 800 ... 1200 RPM.
Ask a Question
K Number
K082010Device Name
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
Manufacturer
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
Date Cleared
2008-12-29
(167 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Product Code :
HBF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stryker Zyphr ™ Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick.
The Stryker Zyphr ™ Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.
Device Description
The Zyphr TM Disposable Cranial Perforator is a mechanically powered tool specifically designed to rapidly create an access hole through the skull in a safe and reliable manner.
Ask a Question
K Number
K082637Device Name
CRANIAL PERFORATOR
Manufacturer
THE ANSPACH EFFORT, INC.
Date Cleared
2008-12-22
(103 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Product Code :
HBF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cranial Perforator is a sterile, single use cutting device intended for performing cranial trephination in bone at least 3 mm thick (i.e., adult skulls).
Device Description
The Cranial Perforator per CFR, Part 882.4305, is a bone cutting and drilling instrument used in conjunction with a surgical motor and speed reducer attachment to drill holes through a patient's skull. The Cranial Perforator employs a clutch mechanism to disengage drilling action upon initial penetration of the skull to prevent plunging of the perforator tip into the underlying dura and brain tissues. The device is a Class II (USA) device. The Cranial Perforator is a device similar in design and construction to other devices currently on the market; (e.g.: Acra-Cut model DGR-1; 14/11mm). The Cranial Perforator is a compound drill which requires a motor to provide speed (70 - 80K RPM) and torque. But a speed reducer attachment is necessary to limit motor speed while delivering necessary torque. For this application the recommended motors are the Anspach Black Max. MicroMax and eMax motor systems. For speed reduction, it is recommended only the Anspach Speed Reducer attachments be used. The speed range when used with the listed Anspach equipment is 800 to 1200 RPM.
Ask a Question
K Number
K073336Device Name
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
Manufacturer
Codman & Shurtleff, Inc.
Date Cleared
2008-01-04
(37 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Product Code :
HBF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K071931Device Name
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
Manufacturer
Codman & Shurtleff, Inc.
Date Cleared
2007-10-22
(101 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Product Code :
HBF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CODMAN® Disposable Perforators are indicated for perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.
Device Description
The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. The perforators consist of a stainless steel inner and outer drill and a stainless steel Hudson End that locks onto a pneumatic or electric driving tool.
Ask a Question
K Number
K032970Device Name
ACRA-CUT XPRESS 120
Manufacturer
ACRA CUT, INC.
Date Cleared
2003-12-08
(76 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Product Code :
HBF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is for use on the skull area only. This device is disposable and for single patient use only. The device is used to aid the surgeon in perforating the skull for various types of purposes. The device does not assist the surgeon during the procedure. Decisions about what to do and how to perform a procedure rest firmly with the surgeon.
Device Description
The ACRA-CUT XPRESS 120 is a battery operated drill that has a skull perforator permanently attached to it. It is for one time use and is delivered charged and sterile.
Ask a Question
Page 1 of 2