SPEEDICATH
Catheter, Urethral
COLOPLAST CORP.
The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Speedicath.
Pre-market Notification Details
| Device ID | K023254 |
| 510k Number | K023254 |
| Device Name: | SPEEDICATH |
| Classification | Catheter, Urethral |
| Applicant | COLOPLAST CORP. 1940 COMMERCE DR. North Mankato, MN 56003 |
| Contact | Elizabeth Boots |
| Correspondent | Elizabeth Boots COLOPLAST CORP. 1940 COMMERCE DR. North Mankato, MN 56003 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-30 |
| Decision Date | 2003-01-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932534475 | K023254 | 000 |
| 05708932653053 | K023254 | 000 |
| 05708932579018 | K023254 | 000 |
| 05708932024754 | K023254 | 000 |
Trademark Results [SPEEDICATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPEEDICATH 75899446 2608545 Live/Registered |
Coloplast A/S 2000-01-19 |
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