The following data is part of a premarket notification filed by Endotherapeutics with the FDA for Uroscan.
| Device ID | K870855 | 
| 510k Number | K870855 | 
| Device Name: | UROSCAN | 
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device | 
| Applicant | ENDOTHERAPEUTICS 191 JEFFERSON DR. Menlo Park, CA 94025 | 
| Contact | Moll, Md | 
| Correspondent | Moll, Md ENDOTHERAPEUTICS 191 JEFFERSON DR. Menlo Park, CA 94025 | 
| Product Code | FAP | 
| CFR Regulation Number | 876.1620 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1987-03-03 | 
| Decision Date | 1987-06-09 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  UROSCAN  77599136  4060357 Live/Registered | SRS MEDICAL SYSTEMS, INC. 2008-10-23 | 
|  UROSCAN  77001824  3689750 Dead/Cancelled | Combimatrix Molecular Diagnostics, Inc. 2006-09-18 | 
|  UROSCAN  73722743  not registered Dead/Abandoned | MCT MEDICAL INC. 1988-04-18 | 
|  UROSCAN  73713229  1510016 Dead/Cancelled | ENDOTHERAPEUTICS 1988-02-25 |