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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 / K261484

510(k) cleared

Tissue Approximation System

Tas Medical, Inc. · Jun 3, 2026 · K261484

FDA cleared the Tissue Approximation System from Tas Medical, Inc. on Jun 3, 2026 under K261484, a special 510(k). The device falls under product code GAR, Suture, Nonabsorbable, Synthetic, Polyamide, regulated at 21 CFR 878.5020 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on May 5, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Tas Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261484?

K261484 is the FDA 510(k) for Tissue Approximation System, submitted by Tas Medical, Inc.. FDA's decision date was Jun 3, 2026, under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide).

Who makes the Tissue Approximation System?

Tas Medical, Inc., based in Windermere, FL, is the applicant of record for K261484.

How long did the K261484 review take?

FDA received the submission on May 5, 2026 and issued its decision on Jun 3, 2026, 29 days later.

← All decisions in June 2026