(65 days)
The TeleMed Systems, Inc. Reusable Biopsy Forceps are indicated for use in obtaining endoscopically tissue samples, retrieval of foreign bodies and stones from the GJ and Urinary tracts and the lungs
Reusable Biopsy Forceps
I am sorry, but the provided text does not contain any information regarding the acceptance criteria, study details, or device performance for the "TeleMed Systems Reusable Biopsy Forceps." The document is an FDA 510(k) clearance letter dated January 21, 1998, which states that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not include any performance data or study design specifics.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.