(10 days)
The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
The Stellartech Coagulation System consists of the following components.
- Stellartech Coagulation Generator ●
- Stellartech Coagulation Probe Connection Module ●
- Stellartech Coagulation Probe ●
- Optional Stellartech Sizing Probe .
- Optional Stellartech Footswitch. .
The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.
This document is a 510(k) premarket notification for the Stellartech Coagulation System. It declares substantial equivalence to previously cleared predicate devices but does not contain any information regarding acceptance criteria or the study that proves the device meets acceptance criteria. This type of submission typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predecessor, often without requiring new clinical performance studies if the technological characteristics and intended use are sufficiently similar.
Therefore, I cannot provide the requested information from 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.