K003443 is an FDA 510(k) clearance for the SUCTION IRRIGATOR. This device is classified as a System, Evacuator, Fluid (Class II - Special Controls, product code FHF).
Submitted by Applied Medical (Rancho Santa, US). The FDA issued a Cleared decision on February 1, 2001, 87 days after receiving the submission on November 6, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4370.
| 510(k) Number | K003443 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2000 |
| Decision Date | February 01, 2001 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FHF - System, Evacuator, Fluid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4370 |