(197 days)
The Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories is designed to dissect, grasp, manipulate and/or cauterise various tissues during manual operations in minimally invasive surgery and general endoscopic/laparoscopic procedures.
Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories
This is an FDA 510(k) clearance letter for the "Logic Laparoscopic Instrument System". It states that the device is substantially equivalent to legally marketed predicate devices. The letter itself does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Therefore, I cannot extract the requested information from the provided text. The document is a regulatory clearance letter, not a detailed study report.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.