Clearance Summary
DropSafe Safety Pen Needle received FDA 510(k) clearance under submission number K170988, sponsored by Htl-Strefa S.A. 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 2017-12-12.
- Submission: K170988
- Applicant / Sponsor: Htl-Strefa S.A
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2017-12-12
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.