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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 / K253263

510(k) cleared

ConvaVAC Negative Pressure Wound Therapy System

Convatec Limited, Gdc Building · Jun 24, 2026 · K253263

FDA cleared the ConvaVAC Negative Pressure Wound Therapy System from Convatec Limited, Gdc Building on Jun 24, 2026 under K253263, a traditional 510(k). The device falls under product code OMP, Negative Pressure Wound Therapy Powered Suction Pump, regulated at 21 CFR 878.4780 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 29, 2025. The decision came 268 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 Convatec Limited, Gdc Building in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253263?

K253263 is the FDA 510(k) for ConvaVAC Negative Pressure Wound Therapy System, submitted by Convatec Limited, Gdc Building. FDA's decision date was Jun 24, 2026, under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).

Who makes the ConvaVAC Negative Pressure Wound Therapy System?

Convatec Limited, Gdc Building, based in Deeside, Flintshire, is the applicant of record for K253263.

How long did the K253263 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 24, 2026, 268 days later.

← All decisions in June 2026