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Found 10 results
510(k) Data Aggregation
K Number
K244001Device Name
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
Manufacturer
KARL STORZ SE & CO. KG
Date Cleared
2025-05-02
(127 days)
Product Code
FBO
Regulation Number
876.1500Why did this record match?
Product Code :
FBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.
Device Description
The KARL STORZ Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11272CU1 / 11272C2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.
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K Number
K243409Device Name
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
Manufacturer
KARL STORZ SE & CO. KG
Date Cleared
2024-11-27
(26 days)
Product Code
FBO
Regulation Number
876.1500Why did this record match?
Product Code :
FBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
Device Description
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11274BCU1) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
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K Number
K131364Device Name
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2014-01-02
(234 days)
Product Code
FBO, FLE
Regulation Number
876.1500Why did this record match?
Product Code :
FBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.
Device Description
The Flexible CMOS-Video-Cysto-Urethroscope system consists of an endoscope and a monitor. The endoscope is a single device and can be said to be made up of an instrument handle, a shaft and a video connector cable. The handle has three camera control buttons, a deflection control lever and a luer connector to the working channel. An LED located in the handle and is use to provide the illumination for visualization of the anatomy under examination. The light is transmitted from the LED to the distal tip via glass fiber light bundles, where it is used to illuminate the body cavity under examination. The CMOS imaging sensor is located at the distaltip of the endoscope shaft captures the reflected light and converts it to a standard NTSC video signal. The luer connector and working channel are used as an introduction port for irrigation fluid and endoscopic instruments. The 8402ZX monitor provides visualization of the image being captured by the CMOS chip in the endoscope. During the procedure, the physician can use the control buttons on the monitor to perform functions, such as video and single image capture.
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K Number
K082046Device Name
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2008-10-10
(84 days)
Product Code
FBO
Regulation Number
876.1500Why did this record match?
Product Code :
FBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories are intended used for by a physican in thevisual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
Device Description
The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories includes a flexible endoscope and accessory items designed for treatment of urological endoscopic procedures. The Karl Storz Pediatric Flexible Cysto-Urethnel Fiberscope is a Class II device under 21CFR876.1500, Endoscope and accessories.
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K Number
K080780Device Name
ANCHORAGE SCOPE, MODEL 000003
Manufacturer
EPITEK, INC.
Date Cleared
2008-07-30
(133 days)
Product Code
FBO, GCJ
Regulation Number
876.1500Why did this record match?
Product Code :
FBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anchorage™ Scope is a flexible fiber optic endoscope intended for the visualization of body cavities, organs, canals, and tissues. The Anchorage Scope is designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The Anchorage Scope is indicated for the following applications:
Ureteroscopy Bronchoscopy Thoracoscopy Nasopharyngoscopy/Sinuscopy General laparascopy Urology Gynecology
Device Description
The Anchorage™ Scope is a flexible fiber optic endoscope provided as a sterile single use device. The endoscope is used to visualize body cavities, organs, canals, and tissues. The Anchorage Scope is introduced through natural body cavities or surgical incisions through introducers or trocars, catheters, sheaths or other devices of with lumens having an inside diameter greater than the outside diameter of the endoscope.
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K Number
K062918Device Name
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2007-01-17
(111 days)
Product Code
FBO
Regulation Number
876.1500Why did this record match?
Product Code :
FBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.
Device Description
The KARL STORZ Flexible Video-Urethro-Cystoscope System is use of the Video-Urethro-Cystoscope with Karl Storz CCU and Karl Storz Light source. The body contact portions of the Video-Urethro-Cystoscope are composed of materials used in other Karl Storz devices which have a long history of biocompatibility for human use and are commonly used in medical devices for a wide range of applications.
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K Number
K061646Device Name
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
Manufacturer
LASERSCOPE
Date Cleared
2006-06-27
(15 days)
Product Code
FBO, KOG
Regulation Number
876.1500Why did this record match?
Product Code :
FBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laserscope GDD Cystourethroscope Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological surgery through minimally invasive approach by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: Dilation of the urethra and cold slitting strictures Trans-urethral incision, vaporization, and resection of the prostrate Trans-urethral removal of bladder tumors
Device Description
The 24 Fr GDD Cystourethroscope is designed with a continuous flow outer sheath, a separate inner sheath/bridge, and an obturator. The outer sheath has the inflow and outflow Stopcocks attached to it. The inner sheath/bridge has one integral accessory port and can accommodate one accessory up to 9 Fr in size. The obturator is designed to allow atromatic introduction of the outer sheath in a natural orfice. The true continuous flow design washes away blood and small tissue particles to ensure a clear operative field. The working length is 23.2 cm to allow access to the entire lower urinary tract. The dedicated operative channel stabilizes accessories including laser fibers. The Continuous Flow Laser Cystourethroscope is designed to be used with low viscosity fluids, including normal saline, Glycine, Sorbitol, or Ringer's Lactate, and standard surgical accessories.
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K Number
K011496Device Name
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660
Manufacturer
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Date Cleared
2001-08-10
(87 days)
Product Code
FBO
Regulation Number
876.1500Why did this record match?
Product Code :
FBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cysto-Urethroscopes 'E-Line' and Accessories are used to visualize and manipulate the bladder, urethra and ureter via natural passages.
The sheath is used to house the endoscope, inserts, and attachments. The sheath provides irrigation, water supply and drainage.
The obturator/vlewing obturator serves to insert the sheaths atraumatically. If a viewing obturator is used, the insertion can be observed.
The inserts are used to guide and angle flexible auxiliary instruments.
The attachments (adapters) serve to connect endoscope and sheath.
The forceps/optical forceps and scissors are used for endoscopically controlled grasping, manipulating, cutting, dissecting and removal of tissue, bladder stones and foreign bodies via natural and surgically created passages.
Optical forceps with unipolar HF connections are used for coagulation by means of high frequency currents to treat minor hemorrhages.
Device Description
The Cysto-Urethroscopes "E-Line" submission consists of Sheaths, Obturators, Inserts, Adapters and Optical Forceps.
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K Number
K972979Device Name
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
Manufacturer
SMITH & NEPHEW, INC.
Date Cleared
1997-12-11
(122 days)
Product Code
FBO
Regulation Number
876.1500Why did this record match?
Product Code :
FBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Smith & Nephew Images Cystourethroscopes are indicated for use in the examination of the bladder, urethra and distal ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for use in the endoscopic examination of the bladder, urethra and distal ureters and to perform various diagnostic and therapeutic procedures.
Device Description
The Images Cystourethroscopes and accessories transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a series of optical lenses and prisms. Sheathes and obturators are offered to allow access to the surgical site.
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K Number
K962474Device Name
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
1996-12-20
(178 days)
Product Code
FBO
Regulation Number
876.1500Why did this record match?
Product Code :
FBO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympus FG-6/7/8/9/42/47-1 grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body, and excised tissue endoscopically.
Device Description
The Olympus FG-6/7/8/9/42/47-1 grasping forceps are designed for grasping tissue and/or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.
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