DeviceClearance

Product code OWN— Gastroenterology, Urology

KARL STORZ ICG Imaging System

Classification name
Confocal Optical Imaging
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
62
First cleared
Most recent

FDA classification definition

“Collection of light signals for visualization of cellular microstructures.”

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

Market context for product code OWN

FDA has cleared 62 devices under product code OWN between 2011 and 2026, filed by 26 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 OWN

Adverse events under product code OWN

product code OWN
Malfunction
1,286
Total
1,286

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 OWN

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