510(k) K914978
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1992
- Date Received
- November 6, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Bite Block
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
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.