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FDA 510(k)

PTFE 外科缝合线

K号: K180630 · 2018-04-06

申请人Omnia Spa
决定日期2018-04-06
产品代码NBY
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

PTFE SURGICAL SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Omnia Spa. It received FDA 510(k) clearance on 2018-04-06 under 510(k) number K180630. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PTFE SURGICAL SUTURE?

PTFE SURGICAL SUTURE is a medical device that received FDA 510(k) clearance on 2018-04-06. The listed applicant is Omnia Spa. The 510(k) number is K180630.

When did PTFE SURGICAL SUTURE receive FDA 510(k) clearance?

PTFE SURGICAL SUTURE received FDA 510(k) clearance on 2018-04-06, under 510(k) number K180630.

Who is the listed applicant for PTFE SURGICAL SUTURE?

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

What is the FDA product code for PTFE SURGICAL SUTURE?

The FDA product code for PTFE SURGICAL SUTURE is NBY.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：NBY）

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。

K231277组织态Durastat, LLCK192088GOLNIT 不可吸收 PTFE 外科缝合线Antarma, LLC Dba Golnit SuturesK180992BiotexPurgo Biologics, Inc.K191317StitchKitOrigami SurgicalK181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech CorporationK173922C-PTFETM 外科缝合线Cp Medical, Inc.

官方来源

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