The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Speedicath Flex Coude.
| Device ID | K161672 |
| 510k Number | K161672 |
| Device Name: | SpeediCath Flex Coude |
| Classification | Catheter, Urethral |
| Applicant | Coloplast Corp. 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Rebecca S. Roberts |
| Correspondent | Rebecca S. Roberts Coloplast Corp. 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 | 2016-06-09 |
| Decision Date | 2016-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932017244 | K161672 | 000 |
| 05708932643689 | K161672 | 000 |
| 05708932643672 | K161672 | 000 |
| 05708932643665 | K161672 | 000 |
| 05708932643658 | K161672 | 000 |
| 05708932643610 | K161672 | 000 |
| 05708932643603 | K161672 | 000 |