(26 days)
The TissueLink Sealing Forceps (Bipolar Forceps) is a sterile, single use bipolar electrosurgical device intended to be used in general and thoracic electrosurgical applications for coagulating, sealing and transecting tissue. It is intended for, but not limited to abdominal and thoracic surgery, laparoscopic procedures, endoscopic procedures and thoracoscopic procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)
TissueLink Sealing Forceps, Model 1 21-202-1
The provided document is a 510(k) summary for a device modification, focusing on regulatory approval for the TissueLink Sealing Forceps. It does not contain information about acceptance criteria, device performance testing, or study details. Therefore, I cannot extract the requested information from this document.
§ 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.