K780675 is an FDA 510(k) clearance for the STERILE 100% SILICONE FOLEY CATHETER. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1978, 15 days after receiving the submission on April 24, 1978.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K780675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 1978 |
| Decision Date | May 09, 1978 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |