DeviceClearance

Product code MNK— Gastroenterology, Urology

BITE BLOCK

Classification name
Endoscopic Bite Block
Device class
Class 1
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
6
First cleared
Most recent

FDA classification definition

“To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.”

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

Market context for product code MNK

FDA has cleared 6 devices under product code MNK between 1990 and 1994, filed by 6 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

Top applicants under product code MNK

Recent clearances under product code MNK

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