FGA

Kit, Nephroscope

Product code: FGA
Device name: Kit, Nephroscope
Device class: Class 2
21 CFR: 21 CFR 876.1500
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 10 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-05-01.

Number	Decision date	Applicant	Device name	Summary
K232370	2024-05-01	Karl Storz SE & CO. KG	Percutaneous Nephroscope System	PDF

1 summaries are archived here for direct download.

Official FDA classification page: FGA

Classification and pathway per current FDA publications. Data from openFDA (CC0).