K923497 is an FDA 510(k) clearance for the FLUSHING IRRIGATION SET. This device is classified as a Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (Class II - Special Controls, product code KDH).
Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on March 21, 1994, 614 days after receiving the submission on July 15, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K923497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | July 15, 1992 |
| Decision Date | March 21, 1994 |
| Days to Decision | 614 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDH — Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |