DeviceClearance

Product code PJH— Gastroenterology, Urology

ECLIPSE SYSTEM

Classification name
Dynamic Rectal Control System
Device class
Class 2
Regulation
21 CFR 876.5930
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

“Intended to treat fecal incontinence by controlling the size of the rectal lumen.”

— U.S. Food and Drug Administration, device classification record for product code PJH under 21 CFR 876.5930, via openFDA

Market context for product code PJH

FDA has cleared 2 devices under product code PJH, all in 2015, filed by 2 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.

Top applicants under product code PJH

Recent clearances under product code PJH

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