Clearance Summary
GO-PEN® received FDA 510(k) clearance under submission number K250262, sponsored by Go-Pen Aps. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-04-24.
- Submission: K250262
- Applicant / Sponsor: Go-Pen Aps
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2025-04-24
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.