K931044 is an FDA 510(k) clearance for the OXY-BLOC, a Endoscopic Bite Block (Class I — General Controls, product code MNK), submitted by Gi Supply (Camp Hill, US). The FDA issued a Cleared decision on October 4, 1993, 217 days after receiving the submission on March 1, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K931044 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 1993 |
| Decision Date | October 04, 1993 |
| Days to Decision | 217 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. |