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510(k) Data Aggregation
K Number
K063494Device Name
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
Manufacturer
PRO-MED INSTRUMENTS GMBH
Date Cleared
2007-05-21
(182 days)
Product Code
HBL
Regulation Number
882.4460Why did this record match?
Applicant Name (Manufacturer) :
PRO-MED INSTRUMENTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins are components of a mechanical support system which is used in head and neck surgery when rigid skeletal fixation is required for cranial stabilization and when intra-operative CT or MR Imaging is used.
The DORO® Radiolucent / MRI Compatible Horseshoe Headrest System are components of a mechanical support system which is used in head and neck surgery when non-invasive head support is required and when intra-operative CT or MR Imaging is used.
The DORO® Radiolucent / MRI Compatible Halo System is a system of radiolucent halo rings of varying size and styles that may be used in neurosurgical applications as an arm rest during head and neck surgery when intra-operative CT or MR Imaging is required.
Device Description
The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems are for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary (Skull Clamp with Skull Pins) or when secured noninvasive cranial stabilization (Horseshoe Headrest System) is required and when Intra-Operative CT or MR Imaging is used.
Main components:
- DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System with Skull Pins
- DORO® Radiolucent / MRI Compatible Horseshoe Headrest Systems
- DORO® Radiolucent / MRI Compatible Halo System
The DORO® Radiolucent / MRI Compatible Skull Clamp Headrest System uses a three-point fixation of the head during surgery in the prone, supine, lateral, and sitting positions via the radiolucent Skull Clamp with Skull Pins. The DORO® Radiolucent / MRI Compatible Horseshoe Headrest System is an alternative noninvasive gel-pad cranial stabilization system for prone and supine positioning. The Skull Clamp or Horseshoe Headrests can be connected to Swivel Adaptor which in turn can be connected to the appropriate Transitional Members (of varying lengths). These are all MR-Safe.
The Radiolucent Halo System is a series of radiolucent rings (full, half and quarter rings) with fixation rods to attach to the radiolucent skull clamp described above. It provides a hand rest for the Surgeon and a mounting place for a variety of surgeon tools, such as brain Retractor and a holding tray. The Halo Rings and the Rod Fixation Assembly are all MR-Safe.
The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems are sold non-sterile. The Swivel Adaptor, Skull Clamp and Horseshoe Headrests are intended to be cleaned by the user between uses. For rigid skeletal fixation, the Skull Clamp uses the disposable single-use ceramic (Yttried Zirconium) or Titanium Skull Pins, which are both x-ray and MRI-compatible.
The components of the DORO® Headrest Systems are made of the following materials:
- The Skull Clamp is made of NOVOTEX laminated fabric with phenolic resin (GRP) colored with BASANTOL black X82 liquid and POM (Delrin), PEEK and Polyurethan. MR-Safe.
- The Swivel Adaptor and the Horseshoe Headrest in adult and pediatric versions, the Transitional Members and the Halo Systems are made of Novotex, PEEK and POM. MR-Safe.
- DORO® Radiolucent Disposable Single-Use Skull Pins of Yttried Zirconium or Titanium are X-ray and MRI compatible. MR-Safe.
The DORO® Radiolucent / MRI Compatible Cranial Stabilization and Halo Systems can be used with accessories from the predicate DORO® Headrest System (K001808) with Gel Pads for adults, Headrest supports with one or two Gel Pads, single Pin Holders, dual Pin Holders for adults, dual Pin Holders for children, a Multi-Purpose Skull Clamp with six Pin fixation or three Gel Pads.
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K Number
K070997Device Name
DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX
Manufacturer
PRO-MED INSTRUMENTS GMBH
Date Cleared
2007-05-16
(37 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PRO-MED INSTRUMENTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DORO® Non-Stick Bipolar Forceps are designed to grasp, manipulate and coagulate selected tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.
The DORO® NON-STICK Bipolar Forceps have not been shown to be effective for tubal sterliization or tubal coagulation for sterilization procedures and should not be used for these procedures.
The DORO® Bipolar Reusable Cables are designed to conduct electrical power from the output of a high frequency electrosurgical generator to the instrument.
Device Description
The DORO® Non-Stick Bipolar Forceps are for use in general surgical procedures. These devices are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.
During the coagulation of tissue, the coagulated tissue may stick to the forceps. This undesirable effect can be eliminated by the non-stick properties of the unique solid silver alloy tip forceps of the DORO line. The solid silver allov tip provides excellent thermal properties and eliminates the difficult and time-consuming of the forceps during a procedure. The non-stick properties are permanent since it is not a coating and the non-stick properties are retained through repeated and frequent sterilizations.
Reusable Standard two-pin round connector cables are designed to work with all foot-switching bipolar electrosurgical generators.
The DORO® Bipolar Reusable Cables are non-sterile, reusable bipolar cables of 3 and 5 meters. They are designed to transport electrical power from a high-frequency electrosurgical generator by a foot-activated switch. The cable fittings are compatible for use with: Erbe, Martin, Valleylab, Aesculap and other ES Generator Units with twinpin connectors (2-banana plug). The cables are comprised of silicone (outer insulation), PTFE or FEP (core insulation), and Cu-wire poreless silver plated (wire).
The cable consists of a twin-pin connector (2-banana plug) that is comprised of silver plated bronze and insulated with silicone. The connector cable at the forceps end is comprised of bronze or brass - silver or nickel plated, Stainless Steel 1.4310, PP (Polypropylene or TPE).
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K Number
K032331Device Name
DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
Manufacturer
PRO-MED INSTRUMENTS GMBH
Date Cleared
2003-11-20
(114 days)
Product Code
HBL
Regulation Number
882.4460Why did this record match?
Applicant Name (Manufacturer) :
PRO-MED INSTRUMENTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DORO Radiolucent Headrest System is used in open and percutaneous craniotomies and spinal surgeries for rigid cranial fixation and when intraoperative CT imaging is used.
The DORO® J-ARM Retractor Accessory is used to fix tissue retractor during neurosurgical procedures.
Device Description
The DORO® Radiolucent Headrest System is a device system used as a support during head and neck surgery. It is composed of several components which are fabricated of materials that allow it to be radiolucent on x-ray. These components are:
- 1. the adjustable Base Unit,
- 2. the Skull Clamp, and
- 3. the Swivel Adaptor,
- 4. Horseshoe Headrest Adult and Children
It is suitable for use in adults and children when the appropriate components are selected.
The DORO System uses a three-point fixation of the head during surgery in the prone, supine, lateral, and sitting positions. The double clamping of the Adjustable Base unit provides simultaneous fixation of the lateral and vertical positions. The Crossbar is used for connection to the side rails of standard operating tables for fixation in a sitting position. The Swivel Adaptor is used in the base unit to provide 360 degree rotation.
The DORO Headrest System, except for the disposable Skull Pins, is sold non-sterile. The Base Unit, Swivel Adaptor and Skull Clamp are intended to be cleaned by the user between uses. It is intended to be used with Disposable, Skull Pins which were cleared with the DORO Headrest System (K001808).
The components of the DORO Headrest System are made of the following materials:
Skull Clamp is made of NOVOTEX laminated fabric with phenolic resin (GRP) colored with BASANTOL black X82 liqu1d and POM (Delrin), PEEK and Polyurethan.
The Swivel Adaptor and the Horseshoe Headrest in adult and pediatric versions, made of Novotex, PEEK and POM
The Base is made of Novotex, PEEK, POM and aluminum.
The J-Arm Retractor System is made of aluminum alloy and is not radiolucent.
The DORO Radiolucent Headrest System can also be used with accessories from the predicate DORO Headrest System (K001808) with Elastic Pads for adults, Headrest supports with one or two Elastic Pads, single Pin Holders, dual Pin Holders for adults, dual Pin Holders for children, a Multi-Purpose Skull Clamp with six Pin fixation or three Elastic Pads).
The DORO Radiolucent Headrest System can also be used with the J-Arm Retractor and Halo Retractor Assembly (K001808) which allows for use as a support and retraction device during neurosurgical procedures where retraction of the brain tissue and handrest are needed.
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K Number
K001808Device Name
DORO HEADREST SYSTEM
Manufacturer
PRO-MED INSTRUMENTS GMBH
Date Cleared
2000-08-04
(50 days)
Product Code
HBL
Regulation Number
882.4460Why did this record match?
Applicant Name (Manufacturer) :
PRO-MED INSTRUMENTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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