FDA 510(k)

사베스코프™ 라파스코프 (SAS-A-536L); 제넥스코르® 비디오 처리 유닛 (VPUX-1)

K-번호: K260177 · 2026-02-12

결정일2026-02-12

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Xenocor, Inc.를 신청인으로 등재한 기타 기록

K220872사베스코프5 라파스코프 K193315Xenocor Articulating Xenoscope Laparoscope K171344Xenocor Xenoscope Laparoscopic System K161838Xenocor Xenoscope Laparoscopic System

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