SBS
- 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
该代码近三年的 510(k)(1 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K232177 | 2024-07-10 | Solmedix Co., Ltd. | Lightin System, Lightin, Lightin Generator | FDA |