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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 / October 2025 / K243968

510(k) cleared

Revolve Surgical System

Revolve Surgical, Inc. · Oct 3, 2025 · K243968 · In the directory

FDA cleared the Revolve Surgical System from Revolve Surgical, Inc. on Oct 3, 2025 under K243968, 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 23, 2024. The decision came 284 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 Revolve Surgical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243968?

K243968 is the FDA 510(k) for Revolve Surgical System, submitted by Revolve Surgical, Inc.. FDA's decision date was Oct 3, 2025, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the Revolve Surgical System?

Revolve Surgical, Inc., based in Toronto, is the applicant of record for K243968. The company is listed in the MedDevice Startups directory.

How long did the K243968 review take?

FDA received the submission on Dec 23, 2024 and issued its decision on Oct 3, 2025, 284 days later.

← All decisions in October 2025

Sources

In the startup directory

Revolve Surgical

Surgical & Robotics · Toronto, ON, Canada