FDA 510(k)

薩貝斯科普5 腹腔鏡

K 號：K220872 · 2022-04-20

決定日期2022-04-20

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Saberscope5 Laparoscope is the device name listed in this FDA 510(k) record. The listed applicant is Xenocor, Inc.. It received FDA 510(k) clearance on 2022-04-20 under 510(k) number K220872. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Saberscope5 Laparoscope?

Saberscope5 Laparoscope is a medical device that received FDA 510(k) clearance on 2022-04-20. The listed applicant is Xenocor, Inc.. The 510(k) number is K220872.

When did Saberscope5 Laparoscope receive FDA 510(k) clearance?

Saberscope5 Laparoscope received FDA 510(k) clearance on 2022-04-20, under 510(k) number K220872.

Who is the listed applicant for Saberscope5 Laparoscope?

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

What is the FDA product code for Saberscope5 Laparoscope?

The FDA product code for Saberscope5 Laparoscope is GCJ.

其他以 Xenocor, 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。

K260177Saberscope™ 腹腔鏡 (SAS-A-536L)；Xenocor® 運算單元 (VPUX-1)K193315Xenocor 閃爍式內視鏡腹腔鏡 K171344Xenocor Xenoscope 腹腔鏡系統 K161838Xenocor Xenoscope 腹腔鏡系統

相關器械（代碼：GCJ）

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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