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Found 7 results
510(k) Data Aggregation
K Number
K050308Device Name
THERMAL CAUTERY PROBE
Manufacturer
STARION INSTRUMENTS
Date Cleared
2005-02-25
(17 days)
Product Code
HQR
Regulation Number
886.4100Why did this record match?
Product Code :
HQR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the simultaneous cutting and cauterization of soft tissue during surgery.
Device Description
The Starion Instruments Thermal Cautery Probe is a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Thermal Cautery Probe allows the surgeon to position the probe in the region of tissue to be cauterized. The Thermal Cautery Probe features a handle, a finger/footswitch control and power cord for connection to a Starion Instruments power supply.
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K Number
K990064Device Name
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
Manufacturer
OPHTHALMIC TECHNOLOGIES, INC.
Date Cleared
1999-04-04
(86 days)
Product Code
HQR
Regulation Number
886.4100Why did this record match?
Product Code :
HQR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OTI Di-thex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, and for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.
Device Description
The system consists of a central control unit that supplies radio frequency energy to a handpiece. The unit can be used for standard diathermy procedures, and can be also used as a cutting instrument for membrane dissection in the eye with the appropriate handpieces and tips. Power level is microprocessor-controlled, and the power-level setting is shown by a bar-graph display on the front panel. The system has a set of alarms which alert the user and suspend operation for such cases as overtemperature, overvoltage, and computer errors.
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K Number
K980522Device Name
REFRACTEC MCS-100
Manufacturer
REFRACTEC, INC.
Date Cleared
1998-07-22
(162 days)
Product Code
HQR
Regulation Number
886.4100Why did this record match?
Product Code :
HQR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K972749Device Name
PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)
Manufacturer
C.M. CHANCE LTD.
Date Cleared
1998-03-13
(233 days)
Product Code
HQR
Regulation Number
886.4100Why did this record match?
Product Code :
HQR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pao Bipolar Coaxial Coagulator is for cauterizing microscopic vessels on the conjunctiva and sclera. It is for extraocular surgery and it is not to be used for intraocular surgery (within the anterior or posterior segment of the eye).
Device Description
Not Found
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K Number
K952151Device Name
STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
Manufacturer
STORZ
Date Cleared
1996-03-04
(301 days)
Product Code
HQR
Regulation Number
886.4100Why did this record match?
Product Code :
HQR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Storz Ophthalmic Bipolar Cautery devices are used to control bleeding during ophthalmic surgical procedures using radiofrequency electric current. The D8200 Bipolar Forceps are used during ophthalmic procedures, coagulating extraocular tissue by pinching it between the forcep tips. The D8201 Bipolar Eraser is also used during surgery for cauterization of extraocular vessels, while the D8203 Bipolar Intraocular Eraser is used in posterior ophthalmic surgical procedures to cauterize vessels internal to the eye.
Device Description
Storz D8200 series Ophthalmic Bipolar Cautery devices are accessories to Storz DAISY®, Protege®, and PREMIERE® Ophthalmic Microsurgical Systems. The D8200 is a reusable bipolar forceps, D8201 is a reusable bipolar eraser, and the D8203 is a reusable bipolar intraocular eraser. The D8202 bipolar cord is used to connect the three cautery instruments to the Storz DAISY® Microsurgical System; the D8204 bipolar cord is used to connect the three cautery instruments to the Storz Protege® and PREMIERE® Microsurgical Systems. All three instruments and both cords have Lemo™ locking connectors. The D8200 forceps are composed of surgical grade stainless steel; the D8201 and D8203 erasers are composed of surgical grade stainless steel and spring steel, and liguid crystal polymer insulation. These materials raise no questions of biocompatibility.
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K Number
K955158Device Name
SURGITRON
Manufacturer
ELLMAN INTL., INC.
Date Cleared
1996-02-09
(88 days)
Product Code
HQR
Regulation Number
886.4100Why did this record match?
Product Code :
HQR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K952569Device Name
GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
Manufacturer
GAMP & ASSOC.
Date Cleared
1996-01-05
(214 days)
Product Code
HQR
Regulation Number
886.4100Why did this record match?
Product Code :
HQR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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