FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Nexpowder
K Number: K240994
·
Decision Nov 27, 2024
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
10
Applicant Total
2
Review Days
230
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Basic Information
- Device Name
- Nexpowder
- K Number
- K240994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4456
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nextbiomedical Co., Ltd.
- Date Received
- April 11, 2024
- Decision Date
- November 27, 2024
- Product Code
- QAU
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QAU), ordered by most recent decision date.
Hemospray Endoscopic Hemostat (HEMO-[X])
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Resolv Endoscopic Hemostat System
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PuraStat
FDA 510(k)
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Nexpowder
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Nextbiomedical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K202929 | Nexpowder | Sep 16, 2022 | Substantially Equivalent |