K924764 is an FDA 510(k) clearance for the OVERTUBE FOR ENDSCOPIC LIGATOR. This device is classified as a Endoscopic Bite Block (Class I — General Controls, product code MNK).
Submitted by Superior Healthcare Group, Inc. (Cumberland, US). The FDA issued a Cleared decision on March 15, 1993, 173 days after receiving the submission on September 23, 1992.
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 | K924764 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 1992 |
| Decision Date | March 15, 1993 |
| Days to Decision | 173 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. |