FDA 510(k)

CoolSeal Trinity (30厘米柄，37厘米柄和44厘米柄)

K号: K203183 · 2021-05-06

决定日期2021-05-06

产品代码GEI

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决定实质等同

器械摘要

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 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 2021-05-06 under 510(k) number K203183. 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, 37 cm shaft, and 44 cm shaft)?

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) is a medical device that received FDA 510(k) clearance on 2021-05-06. The listed applicant is Bolder Surgical, LLC. The 510(k) number is K203183.

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

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) received FDA 510(k) clearance on 2021-05-06, under 510(k) number K203183.

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

The FDA product code for CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 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 K211579CoolSeal Trinity (30 cm 架杆)，CoolSeal Trinity (37 cm 架杆)，CoolSeal Trinity (44 cm 架杆)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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