Gastroenterology-Urology Accessories To A Biopsy Instrument
Medical specialty
Gastroenterology, Urology
Device class
1
Regulation number
876.1080
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.