Clearance Summary
Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets received FDA 510(k) clearance under submission number K230838, sponsored by Cardinal Health200, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-07-27.
- Submission: K230838
- Applicant / Sponsor: Cardinal Health200, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2023-07-27
Classification & Regulation
This clearance is catalogued under FDA product code FYA and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.