Gastroenterology-Urology Accessories To A Biopsy Instrument
QFZ · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.1080
Classification
FDA Product Code
QFZ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 876.1080
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.