DeviceClearance

Product code OOW— Gastroenterology, Urology

INSERTEASE

Classification name
Applicator For Rectal Suppository
Device class
Class 1
Regulation
21 CFR 876.4730
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Intended for use in the insertion of suppositories into the rectum”

— U.S. Food and Drug Administration, device classification record for product code OOW under 21 CFR 876.4730, via openFDA

Market context for product code OOW

FDA has cleared 1 device under product code OOW, all in 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OOW

Recent clearances under product code OOW

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