NKX

Needle, Phacoemulsification, Reprocessed

产品代码

NKX

器械名称

Needle, Phacoemulsification, Reprocessed

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 886.4670

FDA 专业组

Ophthalmic

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 历史累计 510(k)

5 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

Needle for phacoemulsification device to remove cataractous lens. Same as needle for main phacoemulsification device and un-reprocessed needle with product code HQC, except this is a "reprocessed" needle. The Phacoemulsification device is NOT reprocessed, just the needle. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.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）。