Search Results
Found 6 results
510(k) Data Aggregation
K Number
K213042Device Name
Supra Non-Stick Bipolar Forceps
Manufacturer
Guenter Bissinger Medizintechnik GmbH
Date Cleared
2022-11-17
(421 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Guenter Bissinger Medizintechnik GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bissinger SUPRA Non-Stick Bipolar Forceps are used for grasping, dissection and coagulation of biological tissues. The fully assembled instrument (if assembly is needed) has to be connected - with the appropriate cable - to the bipolar output of an HF generator. Supra Non-Stick Bipolar Forceps may not be used for tubal sterilization or tubal coagulation.
Device Description
SUPRA Non-Stick Bipolar Forceps are available in several working length and tip width. They are delivered with a 2pin plug to connect them to bipolar output of an HF generator. The devices are supplied in sterile state and are intended for single use only.
Ask a Question
K Number
K150024Device Name
Bissinger Monopolar Cables
Manufacturer
GUENTER BISSINGER MEDIZINTECHNIK GMBH
Date Cleared
2015-02-20
(44 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
GUENTER BISSINGER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cables for electrosurgery are designed to conduct electrical power from the output of a high-frequency electrosurgical generator to the electrosurgical instrument. Do not exceed a maximum output of 6250 Vp of your generator.
Device Description
Bissinger monopolar cables are non-sterile, reusable Monopolar Cables fitting Bovie Electrosurgical units. They are designed to conduct electrical power from the output of a high frequency generator to the instrument.
Ask a Question
K Number
K051429Device Name
CLARIS NON-STICK BIPOLAR FORCEPS
Manufacturer
GUENTER BISSINGER MEDIZINTECHNIK GMBH
Date Cleared
2005-07-29
(58 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
GUENTER BISSINGER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bissinger CLARIS NON-STICK bipolar forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current.
The Bissinger CLARIS NON-STICK bipolar forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Device Description
During the coagulation of tissue the coagulated tissue might stick to the tip of the forceps. This undesirable effect can almost completely be avoided by using the new CLARIS NON-STICK bipolar forceps. By applying a material with excellent thermal properties for the forceps, difficult and time-consuming cleaning of the forceps during an operation is no longer necessary and enables non-stop working. The non-stick effect is permanently ensured and will not be reduced, even if subject to frequent sterilization. By using a suitable connecting cable, CLARIS NON-STICK bipolar forceps can be connected to all high-frequency electrosurgical generators generally used.
Ask a Question
K Number
K042077Device Name
BITECH BIPOLAR SCISSORS
Manufacturer
GUENTER BISSINGER MEDIZINTECHNIK GMBH
Date Cleared
2004-10-27
(86 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
GUENTER BISSINGER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BiTech bipolar scissors are designed for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
The BiTech Bipolar Scissors has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Device Description
BiTech bipolar scissors enable cutting and dissection with simulataneous bipolar coagulation. They can also be used for precise pinpoint or zone coagulation of blood-vessels and tissue. The various working lengths allow the scissors to be used for a large number of applications in open surgery.
A petented construction priciple, which was developed by Dr. J. Manushakian*, ensures that the scissors are both easy to use and to repair. The electrical contacts for both scissor blades are conducted via one section of the handle, i. e. the connection cable only needs to be attached to one ring, which significantly reduces reference duriong handling. The scissor blades are flexibly joined by means of a standard steel scissor screw which does not need to be insulated and, as a result, is not subject to wear.
Ask a Question
K Number
K981919Device Name
BISSINGER CABLES, CAT. NO. 801000XX
Manufacturer
GUENTER BISSINGER MEDIZINTECHNIK GMBH
Date Cleared
1998-08-06
(66 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
GUENTER BISSINGER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bissinger bipolar cable/cord is intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar output of an electrosurgical generator to a bipolar foot-activated instrument.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Device Description
Bissinger cables are a line of non-sterile, reusable bipolar foot activated cables fitting Erbe, Martin, Valleylab, Aesculap GK50, Codman CMC II, and other ES units.
Ask a Question
K Number
K970968Device Name
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
Manufacturer
GUENTER BISSINGER MEDIZINTECHNIK GMBH
Date Cleared
1998-05-21
(430 days)
Product Code
HET
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
GUENTER BISSINGER MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bipolar tissue coagulation in: Gynecology and Laparascopic surgical procedures
Device Description
The bissinger® detachable bipolar coagulation-forceps is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. The device consists of a Forceps Body (grip), Exterior tube (available in three working lengths), Interior tube (sliding tube, available in three working lengths), 1mm Electrode (fluted bit, available in three working lengths), 3mm Electrode (tong-type bit, available in three working lengths), Hirsch-electrode (rippled bar, available in three working lengths), and various types of plugs (Erbe-type, Martin/Berchtold-type, Codman-type, Valleylab-type) to connect to different current generators, and a Cable.
Ask a Question
Page 1 of 1