Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
FDA 510(k) clearance K252908 · decided 2026-03-25
Clearance details
- K-number
- K252908
- Device name
- Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
- Applicant
- Sandstone Medical (Suzhou), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-12
- Decision date
- 2026-03-25
- Days to decision
- 194 days
- Clearance type
- Special
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.