Picoclamp
FDA 510(k) K230281 · Kono Seisakusho Co., Ltd.
510(k) numberK230281
Submission
- Device name
- Picoclamp
- Applicant
- Kono Seisakusho Co., Ltd.
Ichikawa City, JP - Received
- February 1, 2023
- Decision date
- October 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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Questions and answers
When was Picoclamp cleared by the FDA?
Picoclamp (K230281) received a 510(k) decision of Substantially Equivalent on October 23, 2023, 264 days after the submission was received.
What is the product code of K230281?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.