SBS

Laryngeal Injection Set With Led Light

产品代码
SBS
器械名称
Laryngeal Injection Set With Led Light
管理类别
第 1 类(Class I)
21 CFR 条款
21 CFR 874.4420
FDA 专业组
Ear, Nose, Throat
上市路径
豁免 510(k)(仍须遵守通用控制与注册列名)
该代码近三年的 510(k)
1 件
其中 Summary 已存档
0 份,可直接下载
FDA 历史累计 510(k)
1 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

A light guided laryngeal injection set is an ear, nose, and throat manual surgical instrument and is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar

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)(1 件)

数据窗口为最近三年。最新一件:2024-07-10。

510(k) 号批准日期申请人器械名称摘要
K2321772024-07-10Solmedix Co., Ltd.Lightin System, Lightin, Lightin GeneratorFDA
FDA 官方分类页: SBS
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。