K931044 is an FDA 510(k) clearance for the OXY-BLOC. This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.1500. 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..
| 510(k) Number | K931044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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. |