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Sterile, single-patient-use electrosurgical accessory having applications in general endoscopy and laparoscopy such as cholecystectomy and are intended to deliver electrosurgical current for cutting and coagulation of tissue and suction/irrigation functions to the surgical site.

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The provided document is a 510(k) clearance letter for a medical device (ConMed UniversalPLUS® Laparoscopic ABC®/Electrosurgical Electrode) from the FDA dated January 2, 1998. This letter grants permission to market the device based on a determination of substantial equivalence to a legally marketed predicate device.

This type of document (a 510(k) clearance letter) typically does not contain detailed information about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness. This often involves comparing the new device against the predicate device based on its design, materials, and performance specifications, rather than comprehensive clinical trials with detailed acceptance criteria and standalone performance metrics presented in the format requested.

Therefore, I cannot extract the requested information from this document. The document confirms the device's regulatory classification, its intended use, and that it has been cleared for marketing.

To answer your questions, one would need to refer to the original 510(k) submission (which is not provided) and potentially any associated design verification and validation documents, or clinical study reports if such studies were performed to demonstrate substantial equivalence.

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