QFZ
- 产品代码
- QFZ
- 器械名称
- Gastroenterology-Urology Accessories To A Biopsy Instrument
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 876.1080
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 豁免 510(k)（仍须遵守通用控制与注册列名）
FDA 分类定义
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.
FDA 官方分类页： QFZ
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。