Clearance Summary
NEEDLE REMOVER received FDA 510(k) clearance under submission number K881866, sponsored by Howard, Hills & Harsh. 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 1988-11-14.
- Submission: K881866
- Applicant / Sponsor: Howard, Hills & Harsh
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1988-11-14
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.