图拉鼓室成形管输送装置
K号: K252436 · 2026-04-23
广告
决定日期2026-04-23
产品代码ETD
咨询委员会医疗设备监管文本描述翻译如下：
关于[公司/产品名称]的监管信息：
- 美国食品药品监督管理局（FDA）批准号：[510(k)编号]
- 预市场批准（PMA）申请号：[PMA编号]
- 临床试验注册号（NCT）：[NCT编号]
- 医学文献标识符（PMID）：[PMID编号]
- 产品标识符：[标识符]
- 相关政策：医疗监管政策v1
- 更多信息请访问：[URL]
请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。
决定实质等同
器械摘要
Tula Tympanostomy Tube Delivery Device is the device name listed in this FDA 510(k) record. The listed applicant is Tusker Medical, Inc.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K252436. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tula Tympanostomy Tube Delivery Device?
Tula Tympanostomy Tube Delivery Device is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Tusker Medical, Inc.. The 510(k) number is K252436.
When did Tula Tympanostomy Tube Delivery Device receive FDA 510(k) clearance?
Tula Tympanostomy Tube Delivery Device received FDA 510(k) clearance on 2026-04-23, under 510(k) number K252436.
Who is the listed applicant for Tula Tympanostomy Tube Delivery Device?
The FDA 510(k) record lists Tusker Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tula Tympanostomy Tube Delivery Device?
The FDA product code for Tula Tympanostomy Tube Delivery Device is ETD.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：ETD）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K250256Solo+ 鼓室成形术管装置 (TTD), Solo+ TTD, Solo+ (Solo+ 鼓室成形术管手柄 (目录号：12115-100-000) 和 Solo+ 鼓室成形术管卡 (目录号：12115-200-000))Aventamed DacK232702Solo+ 鼓室成形术管装置 (TTD)Aventamed DacK233658Biowy Tym 管道 (TT)Biowy CorporationK232059tympanostomy导管Grace Medical, Inc.K221254Hummingbird 鼓室成形管系统Preceptis Medical, Inc.K200952Hummingbird 鼓室成形管系统Preceptis Medical, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告