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The FlexFinder® ENCAP guidewire is designed to be used to guide and exchange endoscopic accessories and clinical capabilities for biliary procedures. The FlexFinder® guidewire is indicated for selective cannulation of the biliary ducts, including, cystic, pancreatic, and right and left hepatic ducts.

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The provided text is a 510(k) premarket notification letter from the FDA to FlexMedics Corporation for their FlexFinder Gastrointestinal Guidewire. This document is a regulatory approval letter and does not contain any information regarding the acceptance criteria of the device, its performance, or any studies conducted to prove it meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to predicate devices, not on specific performance metrics or clinical study results.

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The FlexFinder® Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The FlexFinder® Guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.

The FlexFinder® Guidewire is available in a nominal diameter of 0.035" with marked and unmarked models encompassing lengths between 260 - 450 cm. The guidewire is constructed of a Nitinol, kink resistant core wire encapsulated in a PTFE coating. The core wire is tapered to provide flexibility of the distal tip. The guidewire is provided in two shaft flexibility's; regular shaft and stiff shaft. The guidewire will be available in both ink marked and unmarked models of each of the shaft flexibility's. For the marked models, the distal portion of the guidewire is marked visually with ink bands to allow for endoscopic detection of wire movement during a clinical procedure. The encapsulated guidewire enables it to be used with wire guided electrosurgical devices providing insulation from the electrosurgical current during a procedure. The insulation meets the AAMI standard for High frequency Therapeutic devices(HF 18) which describes testing for reliability, safety, and effectiveness. The guidewires are packaged, sterilized, and labeled and intended for one procedure use only(disposable).

This document does not contain an acceptance criteria table or a study description of the FlexFinder® Guidewire. The provided text is a summary of safety and effectiveness for a medical device (guidewire) and details its description, intended use, and technological characteristics, as well as a general statement about non-clinical test summaries. It states that the guidewires meet specifications for electrosurgical devices and materials, but it does not provide specific acceptance criteria values or detailed study information.

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