Veincare
FDA 510(k) clearance K251288 · decided 2025-05-14
Clearance details
- K-number
- K251288
- Device name
- Veincare
- Applicant
- Wontech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-25
- Decision date
- 2025-05-14
- Days to decision
- 19 days
- Clearance type
- Special
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- 64, Techno 8-Ro, Yuseong-Gu, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.