FDA 510(k)

Plum Vagiceuticals™ 阴道潤滑栓

K 號：K261909 · 2026-07-06

決定日期2026-07-06

產品代碼NUC

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Plum Vagiceuticals™ Vaginal Moisturizing Suppositories is the device name listed in this FDA 510(k) record. The listed applicant is PCCA, Inc.. It received FDA 510(k) clearance on 2026-07-06 under 510(k) number K261909. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Plum Vagiceuticals™ Vaginal Moisturizing Suppositories?

Plum Vagiceuticals™ Vaginal Moisturizing Suppositories is a medical device that received FDA 510(k) clearance on 2026-07-06. The listed applicant is PCCA, Inc.. The 510(k) number is K261909.

When did Plum Vagiceuticals™ Vaginal Moisturizing Suppositories receive FDA 510(k) clearance?

Plum Vagiceuticals™ Vaginal Moisturizing Suppositories received FDA 510(k) clearance on 2026-07-06, under 510(k) number K261909.

Who is the listed applicant for Plum Vagiceuticals™ Vaginal Moisturizing Suppositories?

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

What is the FDA product code for Plum Vagiceuticals™ Vaginal Moisturizing Suppositories?

The FDA product code for Plum Vagiceuticals™ Vaginal Moisturizing Suppositories is NUC.

其他以 PCCA, Inc. 為申請人之記錄

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K203091黏膜鎖口用膠

相關器械（代碼：NUC）

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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