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The Stryker StrykeFlow Electrocautery Probe is an electrosurgical device which enables the user to have the functions of electrocautery cutting and coagulation along with suction and irrigation in the same tool when used in combination with the Stryker Strykeflow Suction / Irrigator (K934094 and K954726). The Electrocautery Probe includes a variety of tip configurations for those laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single probe is desirable. The tips are packaged non-sterile for reusable purposes, and validated to packaging standard ASTM 4169.
This document is a 510(k) summary for a medical device submitted to the FDA in 1997. It describes the device, its intended use, and its equivalence to predicate devices. However, the document does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot provide the requested table or additional details. The information necessary to answer your questions is not present in the provided text.
§ 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.