K933537 is an FDA 510(k) clearance for the ENCOMPAS COMFORT BLOCK # 0B-10, a Endoscopic Bite Block (Class I — General Controls, product code MNK), submitted by Encompas Unlimited, Inc. (Tierra Verde, US). The FDA issued a Cleared decision on April 8, 1994, 261 days after receiving the submission on July 21, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K933537 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 21, 1993 |
| Decision Date | April 08, 1994 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |