K874493 is an FDA 510(k) clearance for the BELLA - VAC IRRIGATOR. This device is classified as a Evacuator, Gastro-urology (Class II - Special Controls, product code KQT).
Submitted by Bel-Can Industries (Montclair, US). The FDA issued a Cleared decision on February 5, 1988, 95 days after receiving the submission on November 2, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4370.
| 510(k) Number | K874493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1987 |
| Decision Date | February 05, 1988 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KQT — Evacuator, Gastro-urology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4370 |