Clearance Summary
SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE received FDA 510(k) clearance under submission number K944680, sponsored by Researched, Novel Medical Devices (Rn/Md). 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 1995-01-31.
- Submission: K944680
- Applicant / Sponsor: Researched, Novel Medical Devices (Rn/Md)
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1995-01-31
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.