Submission Details
| 510(k) Number | K230838 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 27, 2023 |
| Decision Date | July 27, 2023 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
Cleared
Traditional
Cardinal Health? SmartGown? EDGE Breathable Surgical Gown with ASSIST? Instrument Pockets
Jul 2023
Decision
122d
Days
Class 2
Risk
About This 510(k) Submission
K230838 is an FDA 510(k) clearance for the Cardinal Health? SmartGown? EDGE Breathable Surgical Gown with ASSIST? Instrument Pockets, a Gown, Surgical (Class II — Special Controls, product code FYA), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on July 27, 2023, 122 days after receiving the submission on March 27, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4040.
Device Classification
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4040 |
Manufacturer
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