Automatic Micro Needle System (CODE-X)
FDA 510(k) clearance K252591 · decided 2026-05-13
Clearance details
- K-number
- K252591
- Device name
- Automatic Micro Needle System (CODE-X)
- Applicant
- Woorhi Mechatronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-15
- Decision date
- 2026-05-13
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- QAI
- Device class
- 2
- Regulation number
- 878.4430
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Gunpo-Si, KR
- Third-party review
- No
- Expedited review
- No
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| SER Pen Carain MicroSystem (MP1209SP) (K241355) | Su-Ko Technologies, LLC | 2024-10-09 |
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Recalls involving this device
No recalls on record reference this clearance.