K981286 is an FDA 510(k) clearance for the SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS. This device is classified as a Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (Class II - Special Controls, product code KDH).
Submitted by Armm, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on June 19, 1998, 72 days after receiving the submission on April 8, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K981286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1998 |
| Decision Date | June 19, 1998 |
| Days to Decision | 72 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 |