FDA 510(k)

Exofin 精密笔

K号: K212246 · 2021-09-09

决定日期2021-09-09

产品代码MPN

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决定实质等同

器械摘要

Exofin Precision Pen is the device name listed in this FDA 510(k) record. The listed applicant is Chemence Medical, Inc.. It received FDA 510(k) clearance on 2021-09-09 under 510(k) number K212246. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Exofin Precision Pen?

Exofin Precision Pen is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Chemence Medical, Inc.. The 510(k) number is K212246.

When did Exofin Precision Pen receive FDA 510(k) clearance?

Exofin Precision Pen received FDA 510(k) clearance on 2021-09-09, under 510(k) number K212246.

Who is the listed applicant for Exofin Precision Pen?

The FDA 510(k) record lists Chemence Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exofin Precision Pen?

The FDA product code for Exofin Precision Pen is MPN.

列明Chemence Medical, 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。

K200264Exofin 高粘度局部皮肤粘合剂 K191461Exofin 融合皮肤闭合系统 K171442Exofin 融合皮肤闭合系统 K162352derma+flex QS 高粘度组织粘合剂

相关器械（代码：MPN）

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。

K243990BondEase 2 表面皮肤粘合剂Optmed, Inc.K250950CUTIVA™局部皮肤粘合剂（RM1700）；CUTIVA™ PLUS皮肤闭合系统（RM1739）Okapi Medical, LLC Dba Resivant Medical K234114CUTIVA™局部皮肤粘合剂（RM-1700）；CUTIVA™ PLUS皮肤闭合系统（RM-1739）Okapi Medical, LLC Dba Resivant Medical K233458CM005 标准 (CM005)；CM004 迷你 (CM004)Connexicon Medical , Ltd.K230981Meriglu局部皮肤粘合剂M/s. Meril Endo Surgery Private Limited.K200264Exofin 高粘度局部皮肤粘合剂Chemence Medical, Inc.

官方来源

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