FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Clicky Cross
K Number: K210516
·
Decision May 16, 2022
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
2
Review Days
447
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Basic Information
- Device Name
- Clicky Cross
- K Number
- K210516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Yomura Technologies, Inc.
- Date Received
- February 23, 2021
- Decision Date
- May 16, 2022
- Product Code
- FMG
- 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 |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | FDA class 2 | General Hospital |
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Other Clearances by Yomura Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112542 | YOMURA SAFETY I.V. CATHETER | Feb 8, 2012 | Substantially Equivalent |