K941356 is an FDA 510(k) clearance for the MICROFLOW IRRIGATION SYSTEM. This device is classified as a Catheter, Continuous Irrigation (Class I - General Controls, product code GBQ).
Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on May 19, 1994, 59 days after receiving the submission on March 21, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K941356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1994 |
| Decision Date | May 19, 1994 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GBQ — Catheter, Continuous Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |