K974233 is an FDA 510(k) clearance for the LYSONIX IRRIGATION SYSTEM, a Catheter, Irrigation (Class I — General Controls, product code GBX), submitted by Lysonix, Inc. (Carpinteria, US). The FDA issued a Cleared decision on February 3, 1998, 83 days after receiving the submission on November 12, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K974233 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 1997 |
| Decision Date | February 03, 1998 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4200 |