DeviceClearance

Product code PEA— Gastroenterology, Urology

EPX-4440HD DIGITAL VIDEO PROCESSOR

Classification name
Endoscope, Accessories, Image Post-Processing For Color Enhancement
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
9
First cleared
Most recent

FDA classification definition

“Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.”

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

Market context for product code PEA

FDA has cleared 9 devices under product code PEA between 2013 and 2025, filed by 4 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 PEA

Adverse events under product code PEA

product code PEA
Malfunction
515
Total
515

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PEA

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