The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Re-trace Ureteral Access Sheath, 10/12 French, Length 35 And 45 Cm, Ureteral Access Sheath, 12/14 Ch-fr, Length 35cm, Ur.
| Device ID | K123675 |
| 510k Number | K123675 |
| Device Name: | RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Contact | Brian Schmidt |
| Correspondent | Brian Schmidt COLOPLAST A/S 1601 WEST RIVER ROAD NORTH 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 | 2012-11-30 |
| Decision Date | 2013-03-01 |
| Summary: | summary |