Clearance Summary
Maxcon Sharps Container received FDA 510(k) clearance under submission number K180984, sponsored by Ningbo Maxcon Medical Technology 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 2019-01-03.
- Submission: K180984
- Applicant / Sponsor: Ningbo Maxcon Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2019-01-03
Classification & Regulation
This clearance is catalogued under FDA product code MMK and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.