FDA 510(k)

Cypris精準縫合系統

K 號：K233355 · 2024-01-12

決定日期2024-01-12

產品代碼GAW

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Cypris eXact Suturing System is the device name listed in this FDA 510(k) record. The listed applicant is Cypris Medical. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233355. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cypris eXact Suturing System?

Cypris eXact Suturing System is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Cypris Medical. The 510(k) number is K233355.

When did Cypris eXact Suturing System receive FDA 510(k) clearance?

Cypris eXact Suturing System received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233355.

Who is the listed applicant for Cypris eXact Suturing System?

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

What is the FDA product code for Cypris eXact Suturing System?

The FDA product code for Cypris eXact Suturing System is GAW.

其他以 Cypris Medical 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。

K240185Cypris eXact 緝合定位設備

相關器械（代碼：GAW）

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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