FDA 510(k)

Restrata®

K号: K193583 · 2020-09-25

决定日期2020-09-25

产品代码QSZ

决定实质等同

器械摘要

Restrata® is the device name listed in this FDA 510(k) record. The listed applicant is Acera Surgical, Inc.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K193583. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.

常见问题

What is the Restrata®?

Restrata® is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Acera Surgical, Inc.. The 510(k) number is K193583.

When did Restrata® receive FDA 510(k) clearance?

Restrata® received FDA 510(k) clearance on 2020-09-25, under 510(k) number K193583.

Who is the listed applicant for Restrata®?

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

What is the FDA product code for Restrata®?

The FDA product code for Restrata® is QSZ.

列明Acera Surgical, 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。

K251224Restrata 软组织加固（STR）K223725Restrata® MiniMatrix K172603Cerafix Dura Substitute K170300Restrata 创面基质 K161278Cerafix Dura Substitute K153613Cerafix Dura Substitute

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官方来源

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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。