Endoscopic Bite Block
The Endoscopic Bite Block is a device used during endoscopic procedures to prevent patients from biting down, thereby protecting fragile endoscope equipment, the patient's teeth and gums, and the endoscopist's fingers during oral insertion of the endoscope. It is classified as FDA Class 1 under 21 CFR 876.1500 in the Gastroenterology and Urology specialty, and is 510(k)-exempt. The product code is MNK, and the device is subject to general controls only.
Basic Information
- Product Code
- MNK
- Device Class
- FDA class 1
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944049 | OXYGEN MOUTHGUARD | Oct 11, 1994 | Substantially Equivalent | Endovations, Inc. |
| K933537 | ENCOMPAS COMFORT BLOCK # 0B-10 | Apr 08, 1994 | Substantially Equivalent | Encompas Unlimited, Inc. |
| K931044 | OXY-BLOC | Oct 04, 1993 | Substantially Equivalent | Gi Supply |
| K924764 | OVERTUBE FOR ENDSCOPIC LIGATOR | Mar 15, 1993 | Substantially Equivalent | Superior Healthcare Group, Inc. |
| K914978 | OXYGUARD | Jan 10, 1992 | Substantially Equivalent | Stantex Pty , Ltd. |
| K896691 | BITE BLOCK | Feb 12, 1990 | Substantially Equivalent | Endoscopix |
FEI Numbers
This FDA classification entry is associated with 125 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 125 registration numbers. Click on an entry to view related FDA registrations.