Clearance Summary
Promisemed Safety Huber Needles received FDA 510(k) clearance under submission number K243332, sponsored by Promisemed Hangzhou Meditech 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 2025-03-14.
- Submission: K243332
- Applicant / Sponsor: Promisemed Hangzhou Meditech Co., Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2025-03-14
Classification & Regulation
This clearance is catalogued under FDA product code PTI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.