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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.
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JAN 3 1 1997
2590 Walsh Ave. Santa Clara, CA 95051
SUMMARY SAFETY AND EFFICACY
Device Name
K 963765
Current Classification Name(s): Unipolar Endoscopic Coagulator-Cutter and Accessories, CFR 21 884.4160, Class (II), Product code 85KNF Electrosurgical Cutting and Coagulation Device and Accessories, CFR 21 878.4400, Class (II), Product code 79GEI Gynecologic Laparoscope and Accessories, CFR 21 884.1720, Class (II), Product code 85HET
Common and Usual Name: Electrocautery Probe Stryker StrykeFlow Electrocautery Probe Proprietary Name:
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
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.
The Electrocautery Probe is tested to a voluntary standard for electrosurgical devices, AAMI HF18.
The Electrocautery Probe is constructed of materials which are tested for biocompatibility per ISO-10993 and are safe, effective, and durable for their intended purposes. Sterilization is per AAMI SSSA and is validated for a minimum SAL of 106
The Electrocautery Probe is equivalent in safety and effectiveness to a variety of devices currently marketed including the Valleylab Laparoscopic Handswitch/ Electrodes and the Stryker Strykeflow Suction / Irrigator Accessories. These devices are used in the applications noted above for general suction, irrigation, and electrocautery.
This device does not raise new issues when compared to its predicate devices or uses. Therefore, it is considered substantially equivalent to those devices.
Signature
Tom Keast Design Engineer
§ 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.