FDA 510(k)

Saberscope™ 腹腔鏡 (SAS-A-536L)；Xenocor® 運算單元 (VPUX-1)

K 號：K260177 · 2026-02-12

決定日期2026-02-12

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) is the device name listed in this FDA 510(k) record. The listed applicant is Xenocor, Inc.. It received FDA 510(k) clearance on 2026-02-12 under 510(k) number K260177. 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 Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)?

Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Xenocor, Inc.. The 510(k) number is K260177.

When did Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) receive FDA 510(k) clearance?

Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) received FDA 510(k) clearance on 2026-02-12, under 510(k) number K260177.

Who is the listed applicant for Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)?

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 Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)?

The FDA product code for Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) 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。

K220872薩貝斯科普5 腹腔鏡 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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE選擇系統Karl Storz SE & CO. KG K260972OEV-271MUH LCD 螢幕；OEV-321MUH LCD 螢幕；OEV-431MUH LCD 螢幕Sony Corporation K261139VereSee (VER150、VER200、VER151、VER201、VER200C 及 VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™（EZ Close Port Site Closing Device、EZ Close MAX Port Site Closing Device、EZ Close II Port Site Closing Device）Medical Impact K261614LED LCD 螢幕 (OEV-271H)Lg Electronics.Inc

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。