EASYMADE-TI
FDA 510(k) clearance K252251 · decided 2026-04-09
Clearance details
- K-number
- K252251
- Device name
- EASYMADE-TI
- Applicant
- CG Bio Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-18
- Decision date
- 2026-04-09
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- GXN
- Device class
- 2
- Regulation number
- 882.5330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.