FDA 510(k)

BondEase 2 表面皮肤粘合剂

K号: K243990 · 2025-09-19

决定日期2025-09-19

产品代码MPN

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决定实质等同

器械摘要

BondEase 2 Topical Skin Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Optmed, Inc.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K243990. 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 BondEase 2 Topical Skin Adhesive?

BondEase 2 Topical Skin Adhesive is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Optmed, Inc.. The 510(k) number is K243990.

When did BondEase 2 Topical Skin Adhesive receive FDA 510(k) clearance?

BondEase 2 Topical Skin Adhesive received FDA 510(k) clearance on 2025-09-19, under 510(k) number K243990.

Who is the listed applicant for BondEase 2 Topical Skin Adhesive?

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

What is the FDA product code for BondEase 2 Topical Skin Adhesive?

The FDA product code for BondEase 2 Topical Skin Adhesive is MPN.

列明Optmed, 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。

K241916TearRepair 液体皮肤保护剂

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。

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.K212246Exofin 精密笔Chemence Medical, Inc.K200264Exofin 高粘度局部皮肤粘合剂Chemence Medical, Inc.

官方来源

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