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THE TAPE

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 / July 2026 / K261949

510(k) cleared

NYES Tuff Cuff L3 Disposable Gowns

New York Embroidery Studio · Jul 10, 2026 · K261949

FDA cleared the NYES Tuff Cuff L3 Disposable Gowns from New York Embroidery Studio on Jul 10, 2026 under K261949, a special 510(k). The device falls under product code FYA, Gown, Surgical, regulated at 21 CFR 878.4040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 11, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

New York Embroidery Studio has one other decision in the tracker over the last 12 months: K252575 (Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)).

Questions & Answers

What did FDA clear under K261949?

K261949 is the FDA 510(k) for NYES Tuff Cuff L3 Disposable Gowns, submitted by New York Embroidery Studio. FDA's decision date was Jul 10, 2026, under product code FYA (Gown, Surgical).

Who makes the NYES Tuff Cuff L3 Disposable Gowns?

New York Embroidery Studio, based in Brooklyn, NY, is the applicant of record for K261949.

How long did the K261949 review take?

FDA received the submission on Jun 11, 2026 and issued its decision on Jul 10, 2026, 29 days later.

← All decisions in July 2026

Sources