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FDA 510(k)

CE Deliver (DLV)

K 號：K252480 · 2025-12-19

申請人CapsoVision, Inc.
決定日期2025-12-19
產品代碼NEZ
諮詢委員會GU
決定Substantially Equivalent

器材摘要

CE Deliver (DLV) is the device name listed in this FDA 510(k) record. The listed applicant is CapsoVision, Inc.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K252480. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CE Deliver (DLV)?

CE Deliver (DLV) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is CapsoVision, Inc.. The 510(k) number is K252480.

When did CE Deliver (DLV) receive FDA 510(k) clearance?

CE Deliver (DLV) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K252480.

Who is the listed applicant for CE Deliver (DLV)?

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

What is the FDA product code for CE Deliver (DLV)?

The FDA product code for CE Deliver (DLV) is NEZ.

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其他以 CapsoVision, 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：NEZ）

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。

K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica CorporationK230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)K221590NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies Co., Ltd.

官方來源

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