FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
BeneHold Surgical Incise Drape with CHG antimicrobial II
K Number: K230645
·
Decision Oct 25, 2023
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
449
Applicant Total
1
Review Days
231
Basic Information
- Device Name
- BeneHold Surgical Incise Drape with CHG antimicrobial II
- K Number
- K230645
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Avery Dennison Medical Ltd.
- Date Received
- March 8, 2023
- Decision Date
- October 25, 2023
- Product Code
- KKX
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical | FDA class 2 | General, Plastic Surgery |
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