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510(k) Data Aggregation
K Number
K240506Device Name
KARL STORZ Holders
Manufacturer
KARL STORZ Endoscopy America, Inc
Date Cleared
2024-10-22
(244 days)
Product Code
OCV, GCJ
Regulation Number
876.1500Why did this record match?
Product Code :
OCV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.
Device Description
The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
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K Number
K232405Device Name
ENDOFIX EXO
Manufacturer
AKTORmed GmbH
Date Cleared
2024-04-25
(259 days)
Product Code
OCV
Regulation Number
876.1500Why did this record match?
Product Code :
OCV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.
Device Description
The ENDOFIX EXO is a manually operated surgical device intended to hold endoscopes during general and neurological diagnostic and therapeutic procedures. It emulates an arm which is capable of guiding and positioning an endoscopic camera with several degrees of movement.
lt ensures stable and sensitive positioning of the endoscope and allows the surgeon to work one-handed and/or two-handed. The system provides surgeons with a stable and rocksteady field of vision, even in extreme endoscopic positions. The wide scope of movement provides surgeons with full visibility of the situs. The ENDOFIX exo can be used with both, an endoscope and exoscope.
An integrated DEACTIVATION PUSHBUTTON permits manual movement of the ENDOFIX EXO at the push of a button. In order to reposition a guided endoscopic camera, the ENDOFIX EXO is unlocked by a sterilizable CONTROL at the push of a button. The ENDOFIX EXO is operated by unlocking all 6 axes and subsequent manual positioning using the CONTROL. As soon as the button on the CONTROL is released, all 6 axes are locked again.
Despite its large scope of movement, the ENDOFIX EXO is light-weight and compact and is fastened directly to the OR table by means of a quick-acting clamp. Thus, repositioning with reference to the patient is not necessary even if the OR table is moved in the meantime.
On the rigid endoscope, there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the ENDOFIX EXO.
To allow the surgeon to convert to an open surgery in case of an emergency, the ENDOFIX EXO can be completely mounted or removed by a quick fastener.
During use, the ENDOFIX EXO is covered with a STERILE COVER. The ENDOFIX EXO can be removed from the OR table and stored on the TROLLEY.
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K Number
K190576Device Name
WalterLorenz Surgical Assist Arm Scope Holder
Manufacturer
Biomet Microfixation
Date Cleared
2019-06-05
(91 days)
Product Code
OCV, GCJ
Regulation Number
876.1500Why did this record match?
Product Code :
OCV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc) and accessories during general diagnostic procedures. The device is also intended to hold endoscopes during diagnostic and therapeutic neurologic procedures.
Device Description
The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the WalterLorenz Surgical Assist Arm, which is a Class 1, table-mounted, electromechanical holding arm that has many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
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K Number
K102179Device Name
ENVIEW (TM)
Manufacturer
CAREFUSION 2200
Date Cleared
2010-12-02
(121 days)
Product Code
OCV
Regulation Number
876.1500Why did this record match?
Product Code :
OCV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EnView™ camera controller is intended for use by surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.
Device Description
The EnView™ camera controller is a manually operated mechanical surgical device. It is designed to hold an endoscope during diagnostic and therapeutic surgical procedures. A surgeon can, with one hand, position and reposition the placement of an endoscope during a surgical procedure by simple movements of a control handle. This camera controller eliminates the need for the surgeon to continually hold the endoscope during a surgical procedure.
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K Number
K093616Device Name
V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
Manufacturer
CAREFUSION 2200
Date Cleared
2009-12-23
(34 days)
Product Code
OCV
Regulation Number
876.1500Why did this record match?
Product Code :
OCV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V. Mueller® Camera Controller is intended for use by surgeons for holding rigid endoscopes with diameters from 5 - 10 mm during diagnostic and therapeutic surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.
Device Description
The V.Mueller Camera Controller with Storage Cart is a manually operated, mechanical surgical device. The instrument provides for the one handed control for the positioning/repositioning of an endoscope during surgical procedures. The V.Mueller Camera Controller eliminates the need for the surgeon or assistant to continuously hold the endoscope during surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.
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K Number
K992006Device Name
NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1999-08-17
(63 days)
Product Code
OCV, GCJ
Regulation Number
876.1500Why did this record match?
Product Code :
OCV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neuroview® Instrument Holder (Model: 300-33) is intended for use in holding Neuro Navigational Neuroview Endoscopes in a desired position over the patient during diagnostic and therapeutic procedures.
Device Description
The Neuroview Instrument Holder, Model 300-33, is a reusable, stainless steel accessory used to hold currently marketed Neuro Navigational Endoscopes. The holder consists of a rail clamp, adjustable stainless steel rods, toggle clamps, and an instrument clamp.
This Instrument Holder, as well as the predicate devices, includes a one-piece design that is completely stable when used to position an instrument. The arms contain adjustable stainless steel clamps and holders that will adapt to any operating room table and hold any Neuro Navigational Endoscope. The holder can be positioned over the patient and locked into place to facilitate accurate Endoscope manipulation and instrument passage. The Instrument Holder, as well as the predicates accessory devices, is sold non-sterile and autoclavable for rapid operating room preparation.
This Instrument Holder is intended to hold the Neuroview Endoscope in place. It has no direct contact with the patient. The only important performance aspect of the Instrument Holder is that it maintains its position once it has been positioned and tightened in place.
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K Number
K990334Device Name
KSEA ENDOSCOPE HOLDER
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
1999-03-22
(47 days)
Product Code
OCV, GCJ
Regulation Number
876.1500Why did this record match?
Product Code :
OCV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This instrument is a manually operated surgical devices intended for Indications for Use: This mistiument is a manadiy operation soopes during diagnostic and therapeutic neurologic procedures.
Device Description
Endoscope Holder
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K Number
K971584Device Name
CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)
Manufacturer
CLARUS MEDICAL SYSTEMS, INC.
Date Cleared
1997-05-23
(23 days)
Product Code
OCV
Regulation Number
876.1500Why did this record match?
Product Code :
OCV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 2127-900 Series Endoscope Adapter is an accessory for the Clarus Medical Systems Model 2127 Endoscope. It is intended to be reusable. It is used to temporarily clamp or hold the endoscope when mounting to an airway catheter.
MOUNT AND 450 ENDOSCOPE ACCESSORY TEST PORARILY 00 USED AIRWAY CATHETER APPRODUATE TOGETHER ENDOSECHE ADD AN
Device Description
The Model 2127-900 Series Endoscope Adapter is a machined or molded plastic piece used to hold an endoscope and airway catheter together. The endoscope adapter has a machined or molded tapered hub designed to fit firmly into the proximal end of various airway catheters. Additionally the endoscope adapter has a central hole designed to fit the outside diameter of the shaft on the appropriate legally marketed Clarus Model 2127 Endoscope.
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K Number
K960068Device Name
SH-1 SURGICAL HOLDER FOR TELESCOPE
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
1997-05-05
(486 days)
Product Code
OCV
Regulation Number
876.1500Why did this record match?
Product Code :
OCV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympus SH-1 Surgical Holder for Telescope can be utilized for the manipulation and positioning of a telescope during laparoscopic procedures.
Device Description
Not Found
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