Clearance Summary
HIgH-Flo Super26 Subcutaneous Needle Sets received FDA 510(k) clearance under submission number K180843, sponsored by Repro-Med Systems, Inc. Dba Rms Medical Products. 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 2019-04-04.
- Submission: K180843
- Applicant / Sponsor: Repro-Med Systems, Inc. Dba Rms Medical Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2019-04-04
Classification & Regulation
This clearance is catalogued under FDA product code FPA and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.