K123258 is an FDA 510(k) clearance for the THE ADVANCE CATHETER FOR HSG AND SIS. This device is classified as a Cannula, Manipulator/injector, Uterine (Class II - Special Controls, product code LKF).
Submitted by Catheter Research, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 31, 2013, 105 days after receiving the submission on October 18, 2012.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K123258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2012 |
| Decision Date | January 31, 2013 |
| Days to Decision | 105 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | LKF — Cannula, Manipulator/injector, Uterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |