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.
| Device Type ID | 1999 |
| Device Name | Endoscopic Bite Block |
| Physical State | Bite Block |
| Technical Method | Placed Into Mouth Over Teeth. |
| Target Area | Mouth |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MNK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1999 |
| Device | Endoscopic Bite Block |
| Product Code | MNK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Material Separation | 7 |
Break | 6 |
Defective Component | 3 |
Device Operates Differently Than Expected | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Material Fragmentation | 1 |
| Total Device Problems | 19 |