K951260 is an FDA 510(k) clearance for the URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on September 27, 1995, 190 days after receiving the submission on March 21, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K951260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1995 |
| Decision Date | September 27, 1995 |
| Days to Decision | 190 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 |