FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Sterile Safety Hypodermic Needles for Single Use
K Number: K231723
·
Decision Sep 8, 2023
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
5
Review Days
87
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Basic Information
- Device Name
- Sterile Safety Hypodermic Needles for Single Use
- K Number
- K231723
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wepon Medical Technology Co., Ltd.
- Date Received
- June 13, 2023
- Decision Date
- September 8, 2023
- Product Code
- FMI
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Wepon Medical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231727 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Sep 8, 2023 | Substantially Equivalent |
| K231720 | Sterile Hypodermic Needles for Single Use | Sep 8, 2023 | Substantially Equivalent |
| K231729 | Sterile syringes for single use with/without needle | Sep 8, 2023 | Substantially Equivalent |
| K212299 | Medical Surgical Mask | Jan 4, 2022 | Substantially Equivalent |