FDA 510(k)

Peri-Guard 和 Supple Peri-Guard

K号: K223052 · 2023-04-07

决定日期2023-04-07

产品代码FTM

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决定实质等同

器械摘要

Peri-Guard and Supple Peri-Guard is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Life Technologies, Inc.. It received FDA 510(k) clearance on 2023-04-07 under 510(k) number K223052. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Peri-Guard and Supple Peri-Guard?

Peri-Guard and Supple Peri-Guard is a medical device that received FDA 510(k) clearance on 2023-04-07. The listed applicant is Synovis Life Technologies, Inc.. The 510(k) number is K223052.

When did Peri-Guard and Supple Peri-Guard receive FDA 510(k) clearance?

Peri-Guard and Supple Peri-Guard received FDA 510(k) clearance on 2023-04-07, under 510(k) number K223052.

Who is the listed applicant for Peri-Guard and Supple Peri-Guard?

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

What is the FDA product code for Peri-Guard and Supple Peri-Guard?

The FDA product code for Peri-Guard and Supple Peri-Guard is FTM.

列明Synovis Life Technologies, 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。

K221032Vascu-Guard 血管修复贴 K221029PERI-GUARD 修复贴，补充 PERI-GUARD 修复贴

官方来源

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