Bite Block
FDA 510(k) K896691 · Endoscopix
510(k) numberK896691
Submission
- Device name
- Bite Block
- Applicant
- Endoscopix
Northridge, CA, US - Received
- November 28, 1989
- Decision date
- February 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MNK – Endoscopic Bite Block
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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.
Other 510(k)s with product code MNK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944049 | Oxygen MouthguardMNK · Traditional | Endovations, Inc. | 10/11/1994SE |
| K933537 | Encompas Comfort Block # 0B-10MNK · Traditional | Encompas Unlimited, Inc. | 04/08/1994SE |
| K931044 | Oxy-BlocMNK · Traditional | Gi Supply | 10/04/1993SE |
| K924764 | Overtube for Endscopic LigatorMNK · Traditional | Superior Healthcare Group, Inc. | 03/15/1993SE |
| K914978 | OxyguardMNK · Traditional | Stantex Pty , Ltd. | 01/10/1992SE |
Questions and answers
When was Bite Block cleared by the FDA?
Bite Block (K896691) received a 510(k) decision of Substantially Equivalent on February 12, 1990, 76 days after the submission was received.
What is the product code of K896691?
The FDA product code is MNK – Endoscopic Bite Block, a Class I (low risk) device regulated under 21 CFR 876.1500.