Clearance Summary
HOLMED HAND HELD INSTRUMENTS received FDA 510(k) clearance under submission number K913810, sponsored by Performance Surgical Instruments Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1991-12-19.
- Submission: K913810
- Applicant / Sponsor: Performance Surgical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1991-12-19
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.