QFZ — Gastroenterology-Urology Accessories To A Biopsy Instrument Class I
FDA product code QFZ covers "Gastroenterology-Urology Accessories To A Biopsy Instrument", a Class I medical device regulated under 21 CFR 876.1080. Submissions are reviewed by the Gastroenterology, Urology panel.
Classification Details
- Product Code
- QFZ
- Device Class
- Class I
- Regulation Number
- 876.1080
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.