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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 / January 2026 / K254014

510(k) cleared

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

Stryker Endoscopy · Jan 13, 2026 · K254014

FDA cleared the Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control from Stryker Endoscopy on Jan 13, 2026 under K254014, 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 Dec 15, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Stryker Endoscopy has 7 other decisions in the tracker over the last 12 months: K262369 (AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down), DEN250040 (SportSuite Vision Software), K253602 (Precision S 4K Sinuscope), K261037 (780 nm SPY Portable Handheld Imaging (SPY-PHI) System).

Questions & Answers

What did FDA clear under K254014?

K254014 is the FDA 510(k) for Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control, submitted by Stryker Endoscopy. FDA's decision date was Jan 13, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control?

Stryker Endoscopy, based in San Jose, CA, is the applicant of record for K254014.

How long did the K254014 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Jan 13, 2026, 29 days later.

← All decisions in January 2026