免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

SILKBridge

K号: K260245 · 2026-04-09

申请人KLISBio S.r.l.
决定日期2026-04-09
产品代码JXI
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

SILKBridge is the device name listed in this FDA 510(k) record. The listed applicant is KLISBio S.r.l.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K260245. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SILKBridge?

SILKBridge is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is KLISBio S.r.l.. The 510(k) number is K260245.

When did SILKBridge receive FDA 510(k) clearance?

SILKBridge received FDA 510(k) clearance on 2026-04-09, under 510(k) number K260245.

Who is the listed applicant for SILKBridge?

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

What is the FDA product code for SILKBridge?

The FDA product code for SILKBridge is JXI.

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：JXI）

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。

K253363NeuroSpan 桥Auxilium Biotechnologies, Inc.K251505VersaCoat 神经保护器（VTP-44G2）；VersaCoat 神经保护器（VTP-12G1）Alafair BiosciencesK251175VersaWrap 神经保护器（VTP-2201）；VersaWrap 神经保护器（VTP-1201）Alafair BiosciencesK243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.K242113神经缠绕（07-DW-001-TAB）Biocircuit Technologies, Inc.K233322Mochida神经袖Mochida Pharmaceutical Co., Ltd.

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。

↑