| K-number | K160217 |
| Device name | uVue HSG/SHG Catheter |
| Applicant | Cook Incorporated |
| Product code | LKF |
| Device class | Class II |
| Decision date | Oct 6, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 884.4530 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov