FDA 510(k)

CollOvine™ 瘘口粉末

K 號：K253140 · 2026-02-10

決定日期2026-02-10

產品代碼KGN

決定相當於

器材摘要

CollOvine™ Wound Powder is the device name listed in this FDA 510(k) record. The listed applicant is Ovigenex, LLC. It received FDA 510(k) clearance on 2026-02-10 under 510(k) number K253140. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常見問題

What is the CollOvine™ Wound Powder?

CollOvine™ Wound Powder is a medical device that received FDA 510(k) clearance on 2026-02-10. The listed applicant is Ovigenex, LLC. The 510(k) number is K253140.

When did CollOvine™ Wound Powder receive FDA 510(k) clearance?

CollOvine™ Wound Powder received FDA 510(k) clearance on 2026-02-10, under 510(k) number K253140.

Who is the listed applicant for CollOvine™ Wound Powder?

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

What is the FDA product code for CollOvine™ Wound Powder?

The FDA product code for CollOvine™ Wound Powder is KGN.

其他以 Ovigenex, LLC 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。

K242985CollOvine™ 識別傷口敷料

相關器械（代碼：KGN）

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。

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官方來源

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