Clearance Summary
ULTICARE SAFETY INSULIN SYRINGE received FDA 510(k) clearance under submission number K103011, sponsored by Ulti-Med Intl., Inc.. 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 2011-02-02.
- Submission: K103011
- Applicant / Sponsor: Ulti-Med Intl., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2011-02-02
Classification & Regulation
This clearance is catalogued under FDA product code MEG and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.