MNK

Endoscopic Bite Block

Product code

MNK

Device name

Endoscopic Bite Block

Device class

Class 1

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).