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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.

The Cysto-Urethroscopes "E-Line" submission consists of Sheaths, Obturators, Inserts, Adapters and Optical Forceps.

The provided document is a 510(k) premarket notification summary for the Cysto-Urethroscope "E-Line" and Accessories device. It states that no clinical tests were performed (Section 6.0 of the 510(k) Summary of Safety and Effectiveness). Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, cannot be extracted from this document because no clinical performance data is presented. The submission relies on substantial equivalence to predicate devices and conformance with the Medical Device Directive 93/42/EEC, rather than on new clinical performance data.

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