510(k) K252251
K252251 is an FDA 510(k) premarket notification submitted by CG Bio Co., Ltd. for the device "EASYMADE-TI". The FDA issued a decision of Substantially Equivalent on April 9, 2026. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. CG Bio Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2026
- Date Received
- July 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Cranioplasty, Preformed, Non-Alterable
- Device Class
- Class II
- Regulation Number
- 882.5330
- Review Panel
- NE
- Submission Type