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 |