K931013 is an FDA 510(k) clearance for the FOLEY CATHETER TRAY. This device is classified as a Accessories, Catheter, G-u (Class II — Special Controls, product code KNY).
Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on August 9, 1993, 164 days after receiving the submission on February 26, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K931013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1993 |
| Decision Date | August 09, 1993 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNY — Accessories, Catheter, G-u |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5130 |