FDA 510(k)

Acclarent AERA 鼓室管球囊扩张系统

K号: K253612 · 2026-02-19

决定日期2026-02-19

产品代码PNZ

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

Acclarent AERA Eustachian Tube Balloon Dilation System is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K253612. The device is classified under product code PNZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Acclarent AERA Eustachian Tube Balloon Dilation System?

Acclarent AERA Eustachian Tube Balloon Dilation System is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Acclarent, Inc.. The 510(k) number is K253612.

When did Acclarent AERA Eustachian Tube Balloon Dilation System receive FDA 510(k) clearance?

Acclarent AERA Eustachian Tube Balloon Dilation System received FDA 510(k) clearance on 2026-02-19, under 510(k) number K253612.

Who is the listed applicant for Acclarent AERA Eustachian Tube Balloon Dilation System?

The FDA 510(k) record lists Acclarent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acclarent AERA Eustachian Tube Balloon Dilation System?

The FDA product code for Acclarent AERA Eustachian Tube Balloon Dilation System is PNZ.

列明Acclarent, Inc.为申报人的其他记录

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。

K230742ACCLARENT AERA 腮腺管扩张系统 K231862TruDi® 导航系统 V3（FG-2000-00）K221037TruDi 剃须刀 K201115下一代气球扩张系统 K201174TruDi 治疗器 K193453TruDi探头

查看所有 17 个设备 →

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。