(246 days)
Biopsy forceps are intended for use in collecting tissue samples for histological examination.
Multi-bite Electric (Hot) Biopsy Forceps
This document is a 510(k) clearance letter from the FDA for a medical device called "Multi-bite Electric (Hot) Biopsy Forceps." It determines the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone), or training set information.
The letter confirms the device's classification and regulation, and outlines the general controls and additional controls it may be subject to under FDA regulations. The "Indications for Use" section simply states the intended use of the biopsy forceps is for "collecting tissue samples for histological examination."
Therefore, based solely on the provided text, I cannot provide the requested information about acceptance criteria and the study proving the device meets those criteria. Such details would typically be found in the 510(k) submission itself or related study reports, not in the clearance letter.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).