The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Soules Intrauterine Insemination Catheter.
| Device ID | K163318 |
| 510k Number | K163318 |
| Device Name: | Soules Intrauterine Insemination Catheter |
| Classification | Catheter, Assisted Reproduction |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Naomi N. Funkhouser |
| Correspondent | Naomi N. Funkhouser Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-23 |
| Decision Date | 2017-07-14 |
| Summary: | summary |