FDA 510(k)

STRATAFIX 螺旋 Monocryl，双向无结组织控制装置

K号: K192580 · 2019-12-18

决定日期2019-12-18

产品代码GAM

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2019-12-18 under 510(k) number K192580. 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 STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device?

STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device is a medical device that received FDA 510(k) clearance on 2019-12-18. The listed applicant is ETHICON, Inc.. The 510(k) number is K192580.

When did STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device receive FDA 510(k) clearance?

STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device received FDA 510(k) clearance on 2019-12-18, under 510(k) number K192580.

Who is the listed applicant for STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device?

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 STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device?

The FDA product code for STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device 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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。