(162 days)
The SYNERGETICS VERITAS... Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures. It is designed for use with most available bipolar electrosurgical units, and will provide a means of transmitting and applying cauterization to captured tissue and small bleeding vessels, thereby causing coagulation and hemostasis
The SYNERGETICS VERITAS... Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures.
I am sorry but this document does not contain the information you are looking for. This document is a letter from the FDA to Synergetics, Inc. regarding the clearance of their Veritas Bipolar, Insulated, 0.5MM TIP device (Model N301-005) for marketing. It states that the device has been found substantially equivalent to legally marketed predicate devices.
The document includes:
- Regulatory Class: II
- Product Code: GEI
- Intended Use: The SYNERGETICS VERITAS Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures, specifically for transmitting and applying cauterization to captured tissue and small bleeding vessels, thereby causing coagulation and hemostasis.
However, it does not contain any information regarding acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert adjudication as typically found in a clinical study report or performance evaluation.
§ 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.