K945061 is an FDA 510(k) clearance for the NOPROFILE OLBERT CATHETER SYSTEM. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on March 9, 1995, 146 days after receiving the submission on October 14, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K945061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1994 |
| Decision Date | March 09, 1995 |
| Days to Decision | 146 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 |