(191 days)
The Electroscope, Inc. Bipolar Electrosurgical Pencil is designed as a "Disposable" product. The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.
The Electroscope, Inc. Bipolar Electrosurgical Pencil is designed as a "Disposable" product. The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.
The provided document is a 510(k) premarket notification letter from the FDA to Electroscope, Incorporated, for a Bipolar Electrosurgical Pencil. This type of document does not contain details about specific acceptance criteria or a study proving the device meets those criteria.
The 510(k) process is primarily a demonstration of substantial equivalence to a legally marketed predicate device, not necessarily a demonstration of clinical efficacy or extensive performance studies with detailed acceptance criteria as would be found in a Premarket Approval (PMA) application or a clinical trial report.
Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval based on equivalence, not on a detailed performance study with acceptance criteria.
§ 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.