Clearance Summary
Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) received FDA 510(k) clearance under submission number K253112, sponsored by Hlb Lifescience Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2026-05-21.
- Submission: K253112
- Applicant / Sponsor: Hlb Lifescience Co., Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2026-05-21
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.