FDA 510(k)

GalaSTITCH 吸收性单丝缝合线

K号: K211307 · 2021-05-27

决定日期2021-05-27

产品代码NWJ

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决定实质等同

器械摘要

GalaSTITCH Absorbable Monofilament Suture is the device name listed in this FDA 510(k) record. The listed applicant is Tepha, Inc.. It received FDA 510(k) clearance on 2021-05-27 under 510(k) number K211307. The device is classified under product code NWJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GalaSTITCH Absorbable Monofilament Suture?

GalaSTITCH Absorbable Monofilament Suture is a medical device that received FDA 510(k) clearance on 2021-05-27. The listed applicant is Tepha, Inc.. The 510(k) number is K211307.

When did GalaSTITCH Absorbable Monofilament Suture receive FDA 510(k) clearance?

GalaSTITCH Absorbable Monofilament Suture received FDA 510(k) clearance on 2021-05-27, under 510(k) number K211307.

Who is the listed applicant for GalaSTITCH Absorbable Monofilament Suture?

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

What is the FDA product code for GalaSTITCH Absorbable Monofilament Suture?

The FDA product code for GalaSTITCH Absorbable Monofilament Suture is NWJ.

列明Tepha, 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。

K233999GalaFLEX LITE支架 K202425SurgiLattice scaffold K162922GalaFORM 3D K161092GalaSHAPE 3D

官方来源

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器械摘要

常见问题

相关临床试验

列明Tepha, Inc.为申报人的其他记录

官方来源