K000723 is an FDA 510(k) clearance for the HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC). This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Rochester Medical Corp. (Stewartville, US). The FDA issued a Cleared decision on May 19, 2000, 74 days after receiving the submission on March 6, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K000723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2000 |
| Decision Date | May 19, 2000 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |