NYES Tuff Cuff L3 Disposable Gowns
New York Embroidery Studio · K261949
FDA-authorized Predetermined Change Control Plan
- Company
- New York Embroidery Studio
- 510(k)/De Novo #
- K261949
- Decision date
- 2026-07-10
- Panel
- General, Plastic Surgery
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Unknown
- Monitoring commitment
- Unknown
Other General, Plastic Surgery PCCPs
- K261021EasyWhip FamilyWinter Innovations, Inc.2026-07-01Non-AIHardware
- K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions2026-06-18Non-AIOther
- K252575Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)2026-06-04Non-AIUnknown
- K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.2026-02-13Non-AIUnknown
- K252301Henan Yadu Level 4 Surgical Gowns (Reinforced)Yadu Medical (Henan) Co., Ltd.2026-02-04Non-AIOther
- K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC2026-01-09Non-AIOther
Want the monitoring teardown?
We read the PCCP for NYES Tuff Cuff L3 Disposable Gowns, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
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