DeviceClearance

Product code OCX— Gastroenterology, Urology

ClearCap Distal Attachment

Classification name
Endoscopic Irrigation/Suction System
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
93
First cleared
Most recent

FDA classification definition

“To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.”

— U.S. Food and Drug Administration, device classification record for product code OCX under 21 CFR 876.1500, via openFDA

Market context for product code OCX

FDA has cleared 93 devices under product code OCX between 1976 and 2025, filed by 55 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

last 15 years

Top applicants under product code OCX

Recent clearances under product code OCX

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