MNK — Endoscopic Bite Block Class I
FDA product code MNK covers "Endoscopic Bite Block", a Class I medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MNK
- Device Class
- Class I
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K944049 | endovations | OXYGEN MOUTHGUARD | October 11, 1994 |
| K933537 | encompas unlimited | ENCOMPAS COMFORT BLOCK # 0B-10 | April 8, 1994 |
| K931044 | gi supply | OXY-BLOC | October 4, 1993 |
| K924764 | superior healthcare group | OVERTUBE FOR ENDSCOPIC LIGATOR | March 15, 1993 |
| K914978 | stantex pty | OXYGUARD | January 10, 1992 |
| K896691 | endoscopix | BITE BLOCK | February 12, 1990 |