K962850 is an FDA 510(k) clearance for the TUM-E-VAC. This device is classified as a Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (Class II - Special Controls, product code KDH).
Submitted by Ethox Corp. (Buffalo, US). The FDA issued a Cleared decision on February 21, 1997, 214 days after receiving the submission on July 22, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K962850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1996 |
| Decision Date | February 21, 1997 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDH — Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |