QFZ

Gastroenterology-Urology Accessories To A Biopsy Instrument

Product code: QFZ
Device name: Gastroenterology-Urology Accessories To A Biopsy Instrument
Device class: Class 1
21 CFR: 21 CFR 876.1080
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K) Exempt

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QFZ

Classification and pathway per current FDA publications. Data from openFDA (CC0).