Clearance Summary
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR received FDA 510(k) clearance under submission number K952581, sponsored by Gamp & Assoc.. 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 1996-01-05.
- Submission: K952581
- Applicant / Sponsor: Gamp & Assoc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1996-01-05
Classification & Regulation
This clearance is catalogued under FDA product code MPA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.