FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
K Number: K240434
·
Decision Sep 25, 2024
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
41
Applicant Total
3
Review Days
224
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Basic Information
- Device Name
- RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
- K Number
- K240434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1175
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Li Medical Corporation , Ltd.
- Date Received
- February 14, 2024
- Decision Date
- September 25, 2024
- Product Code
- HHK
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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