FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Safety Winged Blood Collection Sets
K Number: K243806
·
Decision Jan 10, 2025
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
35
Review Days
30
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Basic Information
- Device Name
- Safety Winged Blood Collection Sets
- K Number
- K243806
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- Date Received
- December 11, 2024
- Decision Date
- January 10, 2025
- 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 Promisemed Hangzhou Meditech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
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| K250192 | Verisafe Safety Retractable Insulin Syringes | Dec 10, 2025 | Substantially Equivalent |
| K250961 | Blood collection tube holders | Jun 4, 2025 | Substantially Equivalent |
| K251138 | Promisemed Safety Huber Needles | May 13, 2025 | Substantially Equivalent |
| K243332 | Promisemed Safety Huber Needles | Mar 14, 2025 | Substantially Equivalent |
| K240675 | Endoscopic Injection Needles | Oct 4, 2024 | Substantially Equivalent |
| K242632 | Verifine® Pen Needles | Sep 26, 2024 | Substantially Equivalent |
| K234124 | Single Use Hemoclips | Jul 12, 2024 | Substantially Equivalent |