Product code MNK
- Device name
- Endoscopic Bite Block
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- 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.
- Source
- FDA openFDA device classification dataset