FDA 510(k)

CoolSeal Trinity (30 cm 架杆)，CoolSeal Trinity (37 cm 架杆)，CoolSeal Trinity (44 cm 架杆)

K号: K211579 · 2021-09-07

决定日期2021-09-07

产品代码GEI

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决定实质等同

器械摘要

CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) is the device name listed in this FDA 510(k) record. The listed applicant is Bolder Surgical, LLC. It received FDA 510(k) clearance on 2021-09-07 under 510(k) number K211579. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)?

CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) is a medical device that received FDA 510(k) clearance on 2021-09-07. The listed applicant is Bolder Surgical, LLC. The 510(k) number is K211579.

When did CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) receive FDA 510(k) clearance?

CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) received FDA 510(k) clearance on 2021-09-07, under 510(k) number K211579.

Who is the listed applicant for CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)?

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

What is the FDA product code for CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)?

The FDA product code for CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) is GEI.

列明Bolder Surgical, LLC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。

K231012CoolSeal Trinity K203183CoolSeal Trinity (30厘米柄，37厘米柄和44厘米柄)K203640CoolSeal Reveal K202114CoolSeal 生成器/CSL-200-50，CoolSeal Trinity (30 cm 架杆)/CSL-TR105-30，CoolSeal Trinity (37 cm 架杆)/CSL-TR105-37，CoolSeal Trinity (44 cm 架杆)/CSL-TR105-44，CoolSeal Mini (20cm 架杆)/CSL-MN103-20

相关器械（代码：GEI）

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。

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官方来源

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