FDA 510(k)

BondEase 2 開放性皮膚膠粘劑

K 號：K243990 · 2025-09-19

決定日期2025-09-19

產品代碼MPN

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Optmed, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K241916撕裂修復液皮膚保護劑

相關器械（代碼：MPN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250950CUTIVA™皮膚外用膠粘劑（RM1700）；CUTIVA™ PLUS皮膚閉合系統（RM1739）Okapi Medical, LLC Dba Resivant Medical K234114CUTIVA™皮膚外用膠粘劑（RM-1700）；CUTIVA™ PLUS皮膚閉合系統（RM-1739）Okapi Medical, LLC Dba Resivant Medical K233458CM005標準型 (CM005)；CM004迷你型 (CM004)Connexicon Medical , Ltd.K230981美瑞光局部皮膚膠粘劑M/s. Meril Endo Surgery Private Limited.K212246Exofin精準筆Chemence Medical, Inc.K200264Exofin 高粘度局部皮膚膠粘劑Chemence Medical, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。