The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Re-trace Ureteral Access Sheath.
| Device ID | K102485 |
| 510k Number | K102485 |
| Device Name: | RE-TRACE URETERAL ACCESS SHEATH |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis, MN 55411 |
| Contact | Brian Schmidt |
| Correspondent | Brian Schmidt COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis, MN 55411 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-30 |
| Decision Date | 2010-10-18 |
| Summary: | summary |