EOQ

Bronchoscope (Flexible Or Rigid)

产品代码

EOQ

器械名称

Bronchoscope (Flexible Or Rigid)

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 874.4680

FDA 专业组

Ear, Nose, Throat

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

241 件

FDA 分类定义

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

该代码近三年的 510(k)（42 件）

数据窗口为最近三年。最新一件：2026-07-25。