DeviceClearance

Product code PIH— Gastroenterology, Urology

INFLOW INTRAURETHRAL VALVE-PUMP

Classification name
Urethral Insert With Pump For Bladder Drainage
Device class
Class 2
Regulation
21 CFR 876.5140
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“The device is intended to empty urine from the bladder under patient control.”

— U.S. Food and Drug Administration, device classification record for product code PIH under 21 CFR 876.5140, via openFDA

Market context for product code PIH

FDA has cleared 1 device under product code PIH, all in 2014, filed by 1 applicant company. 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.

Top applicants under product code PIH

Recent clearances under product code PIH

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