Endoscopic Bite Block
FDA product code MNK · Class I (low risk) · 21 CFR 876.1500 · Gastroenterology, Urology
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.
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944049 | Oxygen MouthguardMNK · Traditional | Endovations, Inc. | 10/11/1994SE |
| K933537 | Encompas Comfort Block # 0B-10MNK · Traditional | Encompas Unlimited, Inc. | 04/08/1994SE |
| K931044 | Oxy-BlocMNK · Traditional | Gi Supply | 10/04/1993SE |
| K924764 | Overtube for Endscopic LigatorMNK · Traditional | Superior Healthcare Group, Inc. | 03/15/1993SE |
| K914978 | OxyguardMNK · Traditional | Stantex Pty , Ltd. | 01/10/1992SE |
| K896691 | Bite BlockMNK · Traditional | Endoscopix | 02/12/1990SE |