FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
K Number: K260147
·
Decision Mar 13, 2026
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
158
Applicant Total
3
Review Days
52
Basic Information
- Device Name
- Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
- K Number
- K260147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Kingboom Technology Co., Ltd.
- Date Received
- January 20, 2026
- Decision Date
- March 13, 2026
- Product Code
- BTA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | FDA class 2 | General, Plastic Surgery |
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