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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 / April 2026 / K260089

510(k) cleared

TL-10 Laparoscopic Scope Cleaner

Scopix , Ltd. · Apr 8, 2026 · K260089

FDA cleared the TL-10 Laparoscopic Scope Cleaner from Scopix , Ltd. on Apr 8, 2026 under K260089, 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 Jan 12, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K260089?

K260089 is the FDA 510(k) for TL-10 Laparoscopic Scope Cleaner, submitted by Scopix , Ltd.. FDA's decision date was Apr 8, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the TL-10 Laparoscopic Scope Cleaner?

Scopix , Ltd., based in Amikam, is the applicant of record for K260089.

How long did the K260089 review take?

FDA received the submission on Jan 12, 2026 and issued its decision on Apr 8, 2026, 86 days later.

← All decisions in April 2026