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FDA 510(k)

无菌隔离扩张器，5，10，16mm（MDT-0442S）；无菌，隔离扩张器，20mm（MDT-0469S）

K号: K253580 · 2026-04-26

申请人Tedan Surgical Innovations
决定日期2026-04-26
产品代码PDQ
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

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) is the device name listed in this FDA 510(k) record. The listed applicant is Tedan Surgical Innovations. It received FDA 510(k) clearance on 2026-04-26 under 510(k) number K253580. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)?

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) is a medical device that received FDA 510(k) clearance on 2026-04-26. The listed applicant is Tedan Surgical Innovations. The 510(k) number is K253580.

When did Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) receive FDA 510(k) clearance?

Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) received FDA 510(k) clearance on 2026-04-26, under 510(k) number K253580.

Who is the listed applicant for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)?

The FDA 510(k) record lists Tedan Surgical Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)?

The FDA product code for Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) is PDQ.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：PDQ）

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。

K260992iD3 Nav 解压探头 (NTX-9005)；iD3 球头刺激探头 (NTX-9006)；iD3 Nav 球头探头 (NTX-9007)NeuralytixK243636Neuralytix iD3 系统 (NTX-9001)Neuralytix, LLCK223438TELIGEN 系统外周运动神经刺激指示Medos International SARLK221821ATEC IOM 配件仪器Alphatec Spine, Inc.K220160PediGuard 穿孔螺纹Spineguard S.A.K203684Neurosign V4术中神经监护仪Magstim Company, Ltd.

官方来源

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