DYNE PORT
K 號：K252933 · 2026-06-12
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器材摘要
DYNE PORT is the device name listed in this FDA 510(k) record. The listed applicant is Dyne Medical Group, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K252933. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the DYNE PORT?
DYNE PORT is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Dyne Medical Group, Inc.. The 510(k) number is K252933.
When did DYNE PORT receive FDA 510(k) clearance?
DYNE PORT received FDA 510(k) clearance on 2026-06-12, under 510(k) number K252933.
Who is the listed applicant for DYNE PORT?
The FDA 510(k) record lists Dyne Medical Group, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DYNE PORT?
The FDA product code for DYNE PORT is ODC.
其他以 Dyne Medical Group, Inc. 為申請人之記錄
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相關器械（代碼：ODC）
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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