FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
PICOCLAMP
K Number: K230281
·
Decision Oct 23, 2023
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
2
Review Days
264
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Basic Information
- Device Name
- PICOCLAMP
- K Number
- K230281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kono Seisakusho Co., Ltd.
- Date Received
- February 1, 2023
- Decision Date
- October 23, 2023
- Product Code
- DXC
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | FDA class 2 | Cardiovascular |
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Other Clearances by Kono Seisakusho Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K192420 | Crownjun Nylon Suture | May 29, 2020 | Substantially Equivalent |