Clearance Summary
OPERATING ROOM NEEDLE COUNTER received FDA 510(k) clearance under submission number K923512, sponsored by Sharp-Trap, Inc.. 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 1992-11-23.
- Submission: K923512
- Applicant / Sponsor: Sharp-Trap, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1992-11-23
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.