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FDA 510(k)

LumenEye® X1內視鏡（LX1-SCP-203）；LumenEye® X1消耗品（LX1-CSB-201）；LumenEye® X1消耗品紙盒（25組）（LX1-CSP-201 ）

K 號：K232262 · 2023-11-30

申請人Surgease Innovations Limited
決定日期2023-11-30
產品代碼FAN
諮詢委員會GU
決定相當於

器材摘要

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) is the device name listed in this FDA 510(k) record. The listed applicant is Surgease Innovations Limited. It received FDA 510(k) clearance on 2023-11-30 under 510(k) number K232262. The device is classified under product code FAN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )?

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Surgease Innovations Limited. The 510(k) number is K232262.

When did LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) receive FDA 510(k) clearance?

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) received FDA 510(k) clearance on 2023-11-30, under 510(k) number K232262.

Who is the listed applicant for LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )?

The FDA 510(k) record lists Surgease Innovations Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )?

The FDA product code for LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) is FAN.

相關臨床試驗

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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