DeviceClearance

Product code FEB— Gastroenterology, Urology

COX DISPOSABLE ENDOSCOPE CLEANING BRUSH

Classification name
Accessories, Cleaning, For Endoscope
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
57
First cleared
Most recent

FDA classification definition

“If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”

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

Market context for product code FEB

FDA has cleared 57 devices under product code FEB between 1981 and 2024, filed by 33 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 FEB

Adverse events under product code FEB

product code FEB
Malfunction
3,879
Total
3,879

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 FEB

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