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510(k) Data Aggregation
K Number
K981928Device Name
GALILEO DISPOSABLE ENDOSCOPES
Manufacturer
GALILEO ELECTRO-OPTICS CORP.
Date Cleared
1998-08-06
(65 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
GALILEO ELECTRO-OPTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Galileo Disposable Endoscopes are endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Disposable Endoscopes are designed to be introduced through natural body cavities or surgical incisions through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope. The Galileo Disposable Endoscopes indications for use include choledoscopy, cystoscopy, ureteroscopy, thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, general laparoscopy and urological applications.
Device Description
The Galileo Disposable Endoscopes are a line of endoscopes based on existing endoscope technology. The Galileo Disposable Endoscopes will be available in various lengths, diameters and configurations for the convenience of the user.
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K Number
K962256Device Name
GALILEO HYSTEROSCOPES AND LAPAROSCOPES
Manufacturer
GALILEO ELECTRO-OPTICS CORP.
Date Cleared
1996-12-06
(177 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
GALILEO ELECTRO-OPTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Galileo Hysteroscopes are rigid endoscopes intended for direct visualization of cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Galileo Laparoscopes are intended for direct visualization of the organs within the peritoneum for diagnostic and surgical procedures on the female genital organs. The Galileo Laparoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope.
Device Description
The Galileo Hysteroscopes and Laparoscopes are a line of reusable rigid endoscopes based on existing endoscope technology. The Galileo Hysteroscopes and Laparoscopes will be available in various lengths, diameters and configurations for the convenience of the user. Two designs of endoscopes are available: Galileo Rod and Lens Design Endoscope and Galileo Fiber Optic Design Endoscope.
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K Number
K962116Device Name
GALILEO ENDOSCOPES
Manufacturer
GALILEO ELECTRO-OPTICS CORP.
Date Cleared
1996-11-27
(180 days)
Product Code
EOB
Regulation Number
874.4760Why did this record match?
Applicant Name (Manufacturer) :
GALILEO ELECTRO-OPTICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Galileo Endoscopes are rigid endoscopes intended for direct visualization of body cavities, hollow organs, and canals. The Galileo Endoscopes are designed to be introduced through natural body cavities or through introducers, needles, trocars, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope. The Galileo Endoscopes indications for use include thoracoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and general laparoscopy.
Device Description
The Galileo Endoscopes are a line of reusable rigid endoscopes based on existing endoscope technology. The Galileo Endoscopes will be available in various lengths, diameters and configurations for the convenience of the user. Two designs of endoscopes are available: Galileo Rod and Lens Design Endoscope and Galileo Fiber Optic Design Endoscope.
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