21 CFR 876.1080 — Gastroenterology-Urology Accessories To A Biopsy Instrument

Gastroenterology, Urology (GU) · Subpart B—Diagnostic Devices · § 876.1080

Identification

A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Product Codes