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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 / P230038

PMA approved

AbsorbaSeal 5.6.7F Vascular Closure Device

Cyndrx, LLC · Jun 5, 2026 · P230038 · In the directory

FDA approved the AbsorbaSeal 5.6.7F Vascular Closure Device from Cyndrx, LLC on Jun 5, 2026 under P230038, an original premarket approval. The device falls under product code MGB, Device, Hemostasis, Vascular as a Class 3 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 17, 2023. The decision came 931 days later.

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

Questions & Answers

What did FDA approve under P230038?

P230038 is the FDA PMA for AbsorbaSeal 5.6.7F Vascular Closure Device, submitted by Cyndrx, LLC. FDA's decision date was Jun 5, 2026, under product code MGB (Device, Hemostasis, Vascular).

Who makes the AbsorbaSeal 5.6.7F Vascular Closure Device?

Cyndrx, LLC, based in Brentwood, TN, is the applicant of record for P230038. The company is listed in the MedDevice Startups directory.

How long did the P230038 review take?

FDA received the submission on Nov 17, 2023 and issued its decision on Jun 5, 2026, 931 days later.

← All decisions in June 2026