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FDA 510(k)

微達辛傷口灌洗溶液

K 號：K261023 · 2026-06-24

申請人Sonoma Pharmaceuticals, Inc.
決定日期2026-06-24
產品代碼FRO
決定相當於

器材摘要

Microdacyn Wound Irrigation Solution is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2026-06-24 under 510(k) number K261023. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Microdacyn Wound Irrigation Solution?

Microdacyn Wound Irrigation Solution is a medical device that received FDA 510(k) clearance on 2026-06-24. The listed applicant is Sonoma Pharmaceuticals, Inc.. The 510(k) number is K261023.

When did Microdacyn Wound Irrigation Solution receive FDA 510(k) clearance?

Microdacyn Wound Irrigation Solution received FDA 510(k) clearance on 2026-06-24, under 510(k) number K261023.

Who is the listed applicant for Microdacyn Wound Irrigation Solution?

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

What is the FDA product code for Microdacyn Wound Irrigation Solution?

The FDA product code for Microdacyn Wound Irrigation Solution is FRO. This falls under the Anesthesiology category.

相關臨床試驗

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其他以 Sonoma Pharmaceuticals, 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。

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相關器械（代碼：FRO）

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