510(k) Report

FDA applicant

New York Embroidery Studio (NYES)

New York, NY1 decision2026–20260 recalls

FDA records 1 decision for New York Embroidery Studio (NYES) (New York, NY) in 2026: 1 510(k) clearance. All are in product code FYA (Gown, Surgical). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided New York Embroidery Studio (NYES)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — New York Embroidery Studio (NYES) by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FYAGown, Surgical1decision

What has FDA decided for it lately?

  • K252575Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES) · 2026

The one decision as New York Embroidery Studio (NYES) →