K841485 is an FDA 510(k) clearance for the UROLOGICAL KIT W/STERILE, WATER-FILL. 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, 1984, 29 days after receiving the submission on April 10, 1984.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K841485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1984 |
| Decision Date | May 09, 1984 |
| Days to Decision | 29 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 |