说明与适用边界
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监管定义 / Regulatory 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.
监管信息 / Regulatory information
FDA product code: QFZ
Device class: 1
Regulation: 876.1080
Specialty: Gastroenterology, Urology
Implant flag: N
Life sustaining/supporting flag: N
使用说明核对
该条目描述监管产品类别，不对应某个型号。实际操作须使用该厂家、型号和软件版本的说明书，核对预期用途、适应证、禁忌、校准、耗材兼容性、清洁灭菌、维护与报警处理。类别资料不能替代厂家使用说明。
来源、版本与许可
- 资料类型
- FDA 器械监管分类（非厂家操作说明书）
- 版本
- 2026-10-08
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.