K102527 is an FDA 510(k) clearance for the IMAGER II UROLOGY TORQUE CATHETER (C1 TIP). This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on November 5, 2010, 64 days after receiving the submission on September 2, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K102527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2010 |
| Decision Date | November 05, 2010 |
| Days to Decision | 64 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 |