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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 / K252697

510(k) cleared

3D Laparoscope

Guangdong Optomedic Technologies, Inc. · Oct 29, 2025 · K252697

FDA cleared the 3D Laparoscope from Guangdong Optomedic Technologies, Inc. on Oct 29, 2025 under K252697, 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 Aug 27, 2025. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

Guangdong Optomedic Technologies, Inc. has one other decision in the tracker over the last 12 months: K252318 (Insufflator (OPTO-IFL1000)).

Questions & Answers

What did FDA clear under K252697?

K252697 is the FDA 510(k) for 3D Laparoscope, submitted by Guangdong Optomedic Technologies, Inc.. FDA's decision date was Oct 29, 2025, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the 3D Laparoscope?

Guangdong Optomedic Technologies, Inc., based in Foshan, is the applicant of record for K252697.

How long did the K252697 review take?

FDA received the submission on Aug 27, 2025 and issued its decision on Oct 29, 2025, 63 days later.

← All decisions in October 2025

Sources