FDA 510(k)

涂层 Vicryl Plus 抗菌 (Polyglactin 910) 可吸收缝合线

K号: K181652 · 2018-09-28

决定日期2018-09-28

产品代码GAM

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决定实质等同

器械摘要

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2018-09-28 under 510(k) number K181652. 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 Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture?

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture is a medical device that received FDA 510(k) clearance on 2018-09-28. The listed applicant is ETHICON, Inc.. The 510(k) number is K181652.

When did Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture receive FDA 510(k) clearance?

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture received FDA 510(k) clearance on 2018-09-28, under 510(k) number K181652.

Who is the listed applicant for Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture?

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

What is the FDA product code for Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture?

The FDA product code for Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture is GAM.

列明ETHICON, 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。

K253394涂层 VICRYL™ (Polyglactin 910) Plus 抗菌缝合线 K252047STRATAFIX® 对称 PDS® Plus 无结组织控制装置 K253572STRATAFIX® 螺旋 PRONOVA® 单向无结组织控制装置 STRATAFIX® 螺旋 PRONOVA® 双向无结组织控制装置 K253852MONOCRYL™ Plus 抗菌多甘露聚糖 – 25（单丝），无菌合成可吸收缝合线 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 K243897PDS™ Plus 抗菌 (聚二氧杂环己酮) 灭菌合成可吸收外科缝合线

查看所有 29 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.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.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

官方来源

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