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510(k) Data Aggregation
K Number
K130669Device Name
SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS
Manufacturer
OLSEN MEDICAL
Date Cleared
2013-12-06
(269 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
OLSEN MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.
Device Description
OLSEN Medical® Electrosurgical Monopolar and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate, cut or coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (bipolar or monopolar) to the specified output terminal of an electrosurgical generator. The bipolar forceps are intended for use with a maximum voltage of 500 volts while the monopolar forceps have a maximum voltage of 2000 volts. The forceps are offered either as single (disposable) or multiple-use (reuseable).
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K Number
K111262Device Name
ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP
Manufacturer
OLSEN MEDICAL
Date Cleared
2012-05-23
(384 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
OLSEN MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olsen Medical Electrosurgical Cables/Adapters is intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
Device Description
The Olsen Medical Electrosurgical Cables/Adapters has been designed as an accessory to various electrosurgical instruments where monopolar/bipolar electrosurgical cutting and coagulation is desired during surgery. Examples of such instruments are; scissors, forceps, dissectors, lap electrodes and handles. The device connects to the high frequency generator on one end and the active instrument on the other end for cutting and coagulation. It is comprised of an insulated cord and a fixed instrument and generator connector on either end as the means of conveying high frequency electrosurgical energy from the generator to the standard electrosurqical instrument during surgery.
The adapter interfaces between the instrument cable and various model of electrosurgical generators to match a proper fit for ESU model output connection.
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K Number
K080187Device Name
OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS
Manufacturer
OLSEN MEDICAL
Date Cleared
2008-05-09
(105 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
OLSEN MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps (Catalog No. 20-0XXX) is a single use product sold sterile and is intended for use in electrosurgery for coagulation and irrigation of tissue. This device is intended for use with the OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set or similar design of Bipolar Cord and Irrigation Tubing.
Device Description
OLSEN MEDICAL Single Use Bayonet Bipolar Irrigating Forceps is packaged sterile with a nonpyrogenic fluid pathway. It consists of an inlet pathway running into a transparent rigid PVC tube attached to the right hand prong of the bayonet forceps. This gives the surgeon a visual of the fluid pathway which facilitates the local fluid irrigation through the forceps. The device is for Single Use Only and is designed for use with bipolar electrosurgical units.
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K Number
K072937Device Name
OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET
Manufacturer
OLSEN MEDICAL
Date Cleared
2007-12-28
(73 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
OLSEN MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set (Catalog No. 40-3xxx) is a single use product sold sterile and is intended for use with a standard bipolar irrigating forceps like the OLSEN MEDICAL Bipolar Irrigating Forceps and the Codman & Shurtleff, Malis™ CMC® Bipolar Systems to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation. This device is intended for use with the Codman/Malis™ CMC® -II and the CODMAN/MALISTM CMC®-III Bipolar Cut and Coagulation System (or equivalent) Electrosurgical Generator.
Bipolar forceps specifically designed for irrigating are required for use with this tubing and cord set. Please read the instruction manuals supplied with the irrigation module and the bipolar coagulator or electrosurgical systems before using this product.
Device Description
The OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set is packaged sterile with a nonpyrogenic fluid pathway. It consists of inlet spike with protective cap, and on/off clamp silicone tubing and fittings, a male LUER-LOK™ connector, two plugs and a female twin-pin socket connector. A co-extrusion process integrates a single use bipolar cord with irrigation tubing set. This integrated set provides the system with one unit delivery conduit and cable for carrying irrigating solution and electrosurgical energy to the Bipolar Irrigation Forceps for coagulation and irrigation of selected tissue.
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K Number
K042073Device Name
OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
Manufacturer
OLSEN MEDICAL
Date Cleared
2005-02-07
(189 days)
Product Code
KWQ, CLA
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
OLSEN MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olsen Medical Dynamic and Semiconstrained Plates are intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc, confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.
Device Description
The Olsen Medical Anterior Cervical Vertebrae Plate System consists of plates and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2 to C7). The Olsen Medical Dynamic and Semiconstrained Plate Systems each come in lengths ranging from 23mm to 109mm. All of the plates, regardless of the length, are 16mm and 19mm wide at the cephalad and caudal ends of the plate, respectively. The Dynamic Plates have slots to receive the screws and the Semiconstrained Plates have round holes to receive the screws. All other plate dimensions are the same. Both plates each have tack holes and drill guide holes at the cephalad and caudal ends of the plate. Both plates are curved both in the longitudinal and lateral planes. The implants of these systems are manufactured from medical grade titanium alloy Ti6 Al4 V meeting the requirements of ASTM F136 or ASTM 1472.
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