FDA 510(k)

Trexon™ 单丝合成可吸收缝合线

K号: K253530 · 2026-05-28

决定日期2026-05-28

产品代码GAM

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决定实质等同

器械摘要

Trexon™ Monofilament Synthetic Absorbable Suture is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K253530. 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 Trexon™ Monofilament Synthetic Absorbable Suture?

Trexon™ Monofilament Synthetic Absorbable Suture is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Medtronic. The 510(k) number is K253530.

When did Trexon™ Monofilament Synthetic Absorbable Suture receive FDA 510(k) clearance?

Trexon™ Monofilament Synthetic Absorbable Suture received FDA 510(k) clearance on 2026-05-28, under 510(k) number K253530.

Who is the listed applicant for Trexon™ Monofilament Synthetic Absorbable Suture?

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

What is the FDA product code for Trexon™ Monofilament Synthetic Absorbable Suture?

The FDA product code for Trexon™ Monofilament Synthetic Absorbable Suture is GAM.

列明Medtronic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。

K251744Affinity Pixie™ 动脉过滤器带Balance™ 生物表面；Affinity® 儿科动脉血过滤器 K233433Sphere-9Dx 诊断导管 (AFR-00009)K240190MYOtherm XP 心肌停搏液输送系统（Cortiva 生物活性表面），MYOtherm XP 心肌停搏液输送系统（未涂层）K223494CD Horizon脊柱系统 K223178SelectSite C304 可弯曲导管系统，C315 递送系统 K222873Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system

查看所有 26 个设备 →

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.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.K253620TroClose 1200Gordian Surgical, Ltd.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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