FDA 510(k)

PDS™ Plus 抗菌 (聚二氧杂环己酮) 灭菌合成可吸收外科缝合线

K号: K243897 · 2025-11-12

决定日期2025-11-12

产品代码NEW

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

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical 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 2025-11-12 under 510(k) number K243897. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture?

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2025-11-12. The listed applicant is ETHICON, Inc.. The 510(k) number is K243897.

When did PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture receive FDA 510(k) clearance?

PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture received FDA 510(k) clearance on 2025-11-12, under 510(k) number K243897.

Who is the listed applicant for PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical 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 PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture?

The FDA product code for PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture is NEW.

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 K221744STRATAFIX® 螺旋 MONOCRYL® Plus 无结组织控制装置

查看所有 29 个设备 →

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。