FDA 510(k)

TroClose 1200

K号: K253620 · 2025-12-16

决定日期2025-12-16

产品代码GAM

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决定实质等同

器械摘要

TroClose 1200 is the device name listed in this FDA 510(k) record. The listed applicant is Gordian Surgical, Ltd.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K253620. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TroClose 1200?

TroClose 1200 is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Gordian Surgical, Ltd.. The 510(k) number is K253620.

When did TroClose 1200 receive FDA 510(k) clearance?

TroClose 1200 received FDA 510(k) clearance on 2025-12-16, under 510(k) number K253620.

Who is the listed applicant for TroClose 1200?

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

What is the FDA product code for TroClose 1200?

The FDA product code for TroClose 1200 is GAM.

列明Gordian Surgical, Ltd.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。

K171494TroClose1200，TroClose1200 管道 K160564TroClose1200

相关器械（代码：GAM）

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。

K253394涂层 VICRYL™ (Polyglactin 910) Plus 抗菌缝合线ETHICON, Inc.K253530Trexon™ 单丝合成可吸收缝合线Medtronic K253852MONOCRYL™ Plus 抗菌多甘露聚糖 – 25（单丝），无菌合成可吸收缝合线ETHICON, Inc.K252743STRATAFIX® 螺旋 PDS® Plus 无结组织控制装置；STRATAFIX® 螺旋 MONOCRYL® Plus 无结组织控制装置ETHICON, Inc.K252820PGLA90 聚(己内酯-co-L-乳酸)外科缝合线（Calypso）；PGLA90 聚(己内酯-co-L-乳酸)外科缝合线（Odysseus）Internacional Farmacéutica S.A DE C.V K233265Monotime 和 Optime RPeters Surgical

官方来源

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