The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Laser Ureteral Catheter.
| Device ID | K181431 |
| 510k Number | K181431 |
| Device Name: | Laser Ureteral Catheter |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Carly Powell |
| Correspondent | Carly Powell Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-01 |
| Decision Date | 2018-07-30 |
| Summary: | summary |