Clearance Summary
Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization received FDA 510(k) clearance under submission number K220057, sponsored by Shinva Ande Healthcare Apparatus Co., Ltd.. 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 2022-10-07.
- Submission: K220057
- Applicant / Sponsor: Shinva Ande Healthcare Apparatus Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2022-10-07
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.