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510(k) Data Aggregation
K Number
K071832Device Name
MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM
Manufacturer
MEDICAL SCIENTIFIC, INC.
Date Cleared
2007-09-18
(77 days)
Product Code
LJH, KOG
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide irrigation during endoscopic surgical procedures
Device Description
Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures. The system is compromised of a pump, foot pedal, and power cord. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed.
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K Number
K063700Device Name
SPYGLASS IRRIGATION SYSTEM
Manufacturer
MEDICAL SCIENTIFIC, INC.
Date Cleared
2007-02-08
(57 days)
Product Code
LJH, KOG
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To provide irrigation during endoscopic surgical procedures
Device Description
Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures.
The system is compromised of a pump, foot pedal, and a sterile single use disposable tubing set. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. The pump provides an adjustable flow-rate from 0 - 45 ml/min at 45 psi. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed. The tubing set will mate with a standard bottle of sterile water or saline and is provided sterile. A portion of the tubing set is placed in the peristaltic pump for flow creation.
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K Number
K031564Device Name
CSS
Manufacturer
MEDICAL SCIENTIFIC, INC.
Date Cleared
2003-10-07
(141 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during various arthroscopic surgical procedures.
Device Description
The CSS is an accessory device that is intended to be used in conjunction with currently marketed automated debrider systems and ESU's the same as the current MSI Bipolar Sheath. The CSS is designed to fit directly over various sizes of straight automated debrider system blades. The CSS will be available in a variety of diameters and in lengths. When the CSS is inserted over one of the debrider blades, the device may be used to cauterize tissue. The CSS can be utilized to provide spot coagulation or to coagulate tissue while the debrider blade is in operation.
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K Number
K011202Device Name
MSI BIPOLAR SHEATH
Manufacturer
MEDICAL SCIENTIFIC, INC.
Date Cleared
2001-12-31
(256 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K981387Device Name
EVANESCE SCAR MANAGEMENT SYSTEM
Manufacturer
MEDICAL SCIENTIFIC, INC.
Date Cleared
1998-06-10
(55 days)
Product Code
MDA
Regulation Number
878.4025Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Evanesce Scar Management System is intended for the over the counter topical management of Hypertrophic and Keloid Scars
Device Description
The Evanesce Scar Management System is composed of a sheet of soft, flexible, translucent silicone elastomer.
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