SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
FDA 510(k) clearance K120127 · decided 2012-10-26
Clearance details
- K-number
- K120127
- Device name
- SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
- Applicant
- Swan Valley Medical, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2012-01-17
- Decision date
- 2012-10-26
- Days to decision
- 283 days
- Clearance type
- Traditional
- Product code
- KOB
- Device class
- 2
- Regulation number
- 876.5090
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Golden, CO, US
- Third-party review
- No
- Expedited review
- No
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| LINDNER/GOLOMB SP INTRODUCING SOUND (K953024) | Cook Urological, Inc. | 1995-08-18 |
| RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE (K952187) | Rusch, Inc. | 1995-07-25 |
Recalls involving this device
No recalls on record reference this clearance.