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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K260177

510(k) cleared

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

Xenocor, Inc. · Feb 12, 2026 · K260177

FDA cleared the Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) from Xenocor, Inc. on Feb 12, 2026 under K260177, a special 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 21, 2026. The decision came 22 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Xenocor, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260177?

K260177 is the FDA 510(k) for Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1), submitted by Xenocor, Inc.. FDA's decision date was Feb 12, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

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

Xenocor, Inc., based in Salt Lake City, UT, is the applicant of record for K260177.

How long did the K260177 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on Feb 12, 2026, 22 days later.

← All decisions in February 2026