K914978 is an FDA 510(k) clearance for the OXYGUARD, a Endoscopic Bite Block (Class I — General Controls, product code MNK), submitted by Stantex Pty , Ltd. (Sydney, New South Wales, AU). The FDA issued a Cleared decision on January 10, 1992, 65 days after receiving the submission on November 6, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K914978 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 1991 |
| Decision Date | January 10, 1992 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| 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. |