K013345 is an FDA 510(k) clearance for the INCARE INTERMITTENT CATHETER. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on January 7, 2002, 90 days after receiving the submission on October 9, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K013345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2001 |
| Decision Date | January 07, 2002 |
| Days to Decision | 90 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 |