(321 days)
Peng's Multifunctional Operative Dissector consists of various types of disposable electrosurgical pencils which are adaptable to common brands of electrosurgical generators for cutting and coagulation to remove tissue and control bleeding by use of high frequency current. Several main models of the electrosurgical pencils can be utilized for suction, and blood, tissue debris, smoke can be removed from the surgical field.
Peng's Multifunctional Operative Dissector (PMOD) consists of various types of disposable electrosurgical pencils which are adaptable to common brands of electrosurgical generators for cutting and coagulation to remove tissue and control bleeding by use of high frequency current. Several main models of the electrosurgical pencils can be utilized for suction, and blood, tissue debris, smoke can be removed from the surgical field.
The provided document is a 510(k) premarket notification letter from the FDA regarding the Peng's Multifunctional Operative Dissector (PMOD). It confirms substantial equivalence to predicate devices but does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on regulatory approval and indications for use, without detailing performance metrics or study designs.
§ 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.