K944135 is an FDA 510(k) clearance for the UROLOGICAL GUIDWIRE. This device is classified as a Accessories, Catheter, G-u (Class II - Special Controls, product code KNY).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on September 21, 1994, 28 days after receiving the submission on August 24, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K944135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1994 |
| Decision Date | September 21, 1994 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNY — Accessories, Catheter, G-u |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |