K875226 is an FDA 510(k) clearance for the ESOPHAGEAL OBTURATOR/TRACHEAL TUBE. This device is classified as a Airway, Esophageal (obturator) (Class II - Special Controls, product code CAO).
Submitted by Sheridan Catheter Corp. (Argyle, US). The FDA issued a Cleared decision on January 19, 1988, 28 days after receiving the submission on December 22, 1987.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5650.
| 510(k) Number | K875226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1987 |
| Decision Date | January 19, 1988 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAO — Airway, Esophageal (obturator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5650 |