The following data is part of a premarket notification filed by Swan Valley Medical, Incorporated with the FDA for Swan Valley Medical Tranurethral Suprapubic Endo-cystostomy (t-spec) Surgical System.
| Device ID | K120127 |
| 510k Number | K120127 |
| Device Name: | SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | SWAN VALLEY MEDICAL, INCORPORATED 16576 W. 53rd Way Golden, CO 80403 |
| Contact | Kevin Randall |
| Correspondent | Kevin Randall SWAN VALLEY MEDICAL, INCORPORATED 16576 W. 53rd Way Golden, CO 80403 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-17 |
| Decision Date | 2012-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856995003010 | K120127 | 000 |
| 00856995003003 | K120127 | 000 |