K011965 is an FDA 510(k) clearance for the IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on July 13, 2001, 18 days after receiving the submission on June 25, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K011965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2001 |
| Decision Date | July 13, 2001 |
| Days to Decision | 18 days |
| Submission Type | Special |
| 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 |