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FDA 510(k)

DropSafe Acti-Lance 安全注射针；滴液 ACTI-LANCE 安全注射针，DropSafe Medlance Plus 安全注射针；滴液 MEDLANCE PLUS 安全注射针，DropSafe ergoLance 安全注射针，DropSafe Prolance 安全注射针，DropSafe Medisafe Solo 安全注射针；DropSafe Haemolance Plus 安全注射针

K号: K220643 · 2022-07-08

申请人Htl-Strefa S.A
决定日期2022-07-08
产品代码FMK
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

DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets is the device name listed in this FDA 510(k) record. The listed applicant is Htl-Strefa S.A. It received FDA 510(k) clearance on 2022-07-08 under 510(k) number K220643. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets?

DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is Htl-Strefa S.A. The 510(k) number is K220643.

When did DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets receive FDA 510(k) clearance?

DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets received FDA 510(k) clearance on 2022-07-08, under 510(k) number K220643.

Who is the listed applicant for DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets?

The FDA 510(k) record lists Htl-Strefa S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets?

The FDA product code for DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets is FMK.

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

列明Htl-Strefa S.A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。

K250016droplet®个人采血针K202340Droplet Pen Needle 30G & 33GK192082Droplet Pen Needle 34GK171982DROPLET 笔式注射针K170988DropSafe 安全笔式注射针

相关器械（代码：FMK）

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。

K262526安全采血针（XL）Tianjin Huahong Technology Co., Ltd.K261045Verifine 安全采血针Promisemed Hangzhou Meditech Co., Ltd.K260191安全型刀片（XXXVII）Tianjin Huahong Technology Co., Ltd.K253605安全足跟注射针Ningbo Medsun Medical Co., Ltd.K252490足跟棒安全刀片（HHZ-II，HHZ-III，HHZ-IV）Tianjin Huahong Technology Co., Ltd.K251694安全注射针Tianjin Huahong Technology Co., Ltd.

官方来源

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