(76 days)
The Olympus Bipolar Forceps has been designed for grasping and coagulation of soft tissue and blood vessels during endoscopic treatment in laparoscopic and gynecological applications.
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The provided text is a 510(k) summary for the OLYMPUS BIPOLAR FORCEPS. It focuses on regulatory approval and substantial equivalence to predicate devices. Crucially, this document does not contain any information regarding specific acceptance criteria, study details, or performance data of the device.
Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically includes a general statement of intended use and a comparison to predicate devices, but it does not usually elaborate on detailed performance studies, acceptance criteria, or ground truth establishment.
To answer your request, I would need a document that describes the specific testing and validation performed for the device's performance, which is not present in this 510(k) summary.
§ 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.