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FDA 510(k)

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

K-Number: K260177 · 2026-02-12

ApplicantXenocor, Inc.
Decision Date2026-02-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) is a medical device manufactured by Xenocor, Inc.. It received FDA 510(k) clearance on 2026-02-12 under approval number K260177. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Xenocor, Inc.. The 510(k) number is K260177.

When was Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) approved by the FDA?

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

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

Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) is manufactured by Xenocor, Inc..

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.

Other Devices by Xenocor, Inc.

K161838Xenocor Xenoscope Laparoscopic System K171344Xenocor Xenoscope Laparoscopic System K193315Xenocor Articulating Xenoscope Laparoscope K220872Saberscope5 Laparoscope

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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