The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Retrace Ureteral Access Sheath.
| Device ID | K181811 |
| 510k Number | K181811 |
| Device Name: | ReTrace Ureteral Access Sheath |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Coloplast A/S 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Cori Ragan |
| Correspondent | Cori Ragan Coloplast A/S 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-06 |
| Decision Date | 2018-09-07 |
| Summary: | summary |