DeviceClearance

Product code KOA— Gastroenterology, Urology

FORDER RETRACTOR

Classification name
Surgical Instruments, G-U, Manual (And Accessories)
Device class
Class 1
Regulation
21 CFR 876.4730
Advisory panel
Gastroenterology, Urology
Total cleared
44
First cleared
Most recent

Market context for product code KOA

FDA has cleared 44 devices under product code KOA between 1976 and 2018, filed by 31 applicant companies. 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.

Clearances per year

last 15 years

Top applicants under product code KOA

Recent clearances under product code KOA

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