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510(k) Data Aggregation
K Number
K980617Device Name
MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
Manufacturer
UROHEALTH SYSTEMS, INC.
Date Cleared
1998-04-09
(76 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
UROHEALTH SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in a variety of open procedures, such as abdominal, pediatric, thoracic, gynecologic, etc. and for use in endoscopic and laparoscopic the assol gynocelling hemostatic transection of vessels and other tissue structures.
Device Description
Richard-Allan's Reflex AEC 35, with shorter shaft length is substantially equivalent to our currently marketed Reflex AEC 35. These instruments have the same component materials, method of manufacturing, and method of sterilization. These instruments have similar instructions for use.
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K Number
K970107Device Name
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
Manufacturer
UROHEALTH SYSTEMS, INC.
Date Cleared
1997-11-18
(309 days)
Product Code
EOQ
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
UROHEALTH SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intubation Endoscope and Introducer Sheath are used in the direct visualization in the trachea and lungs during fiberoptically assisted intubation and airway management.
Device Description
UROHEALTH Intubation Endoscope Introducer Sheath is a device that consists a malleable or nonmalleable introducer sheath that houses a channel for insufflation of oxygen or fluid delivery, a deflecting mechanism for the distal tip, a channel for scope insertion, and a distal window. The reusable fiber optic imaging and illumination system consists of a focusing ocular lens, a distal objective lens, and a connection for a fiber optic light cable.
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K Number
K972510Device Name
PIVOTAL SCISSOR
Manufacturer
UROHEALTH SYSTEMS, INC.
Date Cleared
1997-11-13
(133 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
UROHEALTH SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pivotal devices are sterile, disposable, general surgical instruments for use in endoscopic or open surgical procedures to dissect, transect, manipulate, coagulate, and/or grasp tissue.
Device Description
The Pivotal instrument and similar currently marketed devices are intended to cut, grasp, manipulate, and coagulate tissue during surgical procedures. The similar marketed endoscopic devices are designed to be used with monopolar electrosurgery and are disposable devices supplied sterile to the user. These devices are available in a variety of blade and jaw configurations. These devices have similar thermoplastic ringed handles that open and close the jaws. The grasper devices are all equipped with a ratchet mechanism that allows the tissue to be held in the jaws without the need for applying constant pressure on the ringed handles.
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