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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 / June 2026 / K253994

510(k) cleared

TroKit Laparoscope Lens Wiper

TroCare, LLC · Jun 4, 2026 · K253994

FDA cleared the TroKit Laparoscope Lens Wiper from TroCare, LLC on Jun 4, 2026 under K253994, a traditional 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 12, 2025. The decision came 174 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K253994?

K253994 is the FDA 510(k) for TroKit Laparoscope Lens Wiper, submitted by TroCare, LLC. FDA's decision date was Jun 4, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the TroKit Laparoscope Lens Wiper?

TroCare, LLC, based in Houston, TX, is the applicant of record for K253994.

How long did the K253994 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Jun 4, 2026, 174 days later.

← All decisions in June 2026