DeviceClearance

Product code KPM— Gastroenterology, Urology

DENVER PERITONEO-VENOUS SHUNT

Classification name
Shunt, Peritoneal
Device class
Class 2
Regulation
21 CFR 876.5955
Advisory panel
Gastroenterology, Urology
Total cleared
19
First cleared
Most recent

Market context for product code KPM

FDA has cleared 19 devices under product code KPM between 1977 and 2023, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code KPM

Recent clearances under product code KPM

Data sourced from openFDA. This site is unofficial and independent of the FDA.