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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 / June 2026 / K252575

510(k) cleared

Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)

New York Embroidery Studio (NYES) · Jun 4, 2026 · K252575

FDA cleared the Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) from New York Embroidery Studio (NYES) on Jun 4, 2026 under K252575, a traditional 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 Aug 14, 2025. The decision came 294 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

New York Embroidery Studio (NYES) has one other decision in the tracker over the last 12 months: K261949 (NYES Tuff Cuff L3 Disposable Gowns).

Questions & Answers

What did FDA clear under K252575?

K252575 is the FDA 510(k) for Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L), submitted by New York Embroidery Studio (NYES). FDA's decision date was Jun 4, 2026, under product code FYA (Gown, Surgical).

Who makes the Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)?

New York Embroidery Studio (NYES), based in New York, NY, is the applicant of record for K252575.

How long did the K252575 review take?

FDA received the submission on Aug 14, 2025 and issued its decision on Jun 4, 2026, 294 days later.

← All decisions in June 2026

Sources