FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
K Number: K230838
·
Decision Jul 27, 2023
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
287
Applicant Total
13
Review Days
122
Basic Information
- Device Name
- Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
- K Number
- K230838
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardinal Health 200, LLC
- Date Received
- March 27, 2023
- Decision Date
- July 27, 2023
- Product Code
- FYA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
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