Submission Details
| 510(k) Number | K896691 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 28, 1989 |
| Decision Date | February 12, 1990 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
Cleared
Traditional
BITE BLOCK
Feb 1990
Decision
76d
Days
Class 1
Risk
About This 510(k) Submission
K896691 is an FDA 510(k) clearance for the BITE BLOCK, a Endoscopic Bite Block (Class I — General Controls, product code MNK), submitted by Endoscopix (Northridge, US). The FDA issued a Cleared decision on February 12, 1990, 76 days after receiving the submission on November 28, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | MNK — Endoscopic Bite Block |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.1500 |
| 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. |
Manufacturer
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