K180291 is an FDA 510(k) clearance for the Cook Silicone Balloon HSG Catheter. This device is classified as a Cannula, Manipulator/injector, Uterine (Class II - Special Controls, product code LKF).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 26, 2018, 267 days after receiving the submission on February 1, 2018.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K180291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2018 |
| Decision Date | October 26, 2018 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| 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 |