(183 days)
It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Modern Medical Non Stick Electrode." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document only states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested table and study details from the given text.
The information I can extract, which is not directly related to acceptance criteria or performance studies but is present in the document, includes:
- Trade/Device Name: Modern Medical Non Stick Electrode
- Regulation Number: 21 CFR 878.4400
- Regulation Name: Electrosurgical cutting and coagulation device and accessories
- Regulatory Class: II
- Product Code: GEI
- Indications For Use: It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.
- 510(k) Number: K043036
§ 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.