The following data is part of a premarket notification filed by Coloplast with the FDA for Speedicath Standard.
| Device ID | K180258 |
| 510k Number | K180258 |
| Device Name: | SpeediCath Standard |
| Classification | Catheter, Urethral |
| Applicant | Coloplast 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Ngoc Linh Pham Latchman |
| Correspondent | Troy Thome Coloplast 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-30 |
| Decision Date | 2018-10-25 |
| Summary: | summary |