VPI-FAIR URETHRAL STENT
FDA 510(k) clearance K820313 · decided 1982-03-01
Clearance details
- K-number
- K820313
- Device name
- VPI-FAIR URETHRAL STENT
- Applicant
- Vance Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-05
- Decision date
- 1982-03-01
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050. recall (Z-0966-2011) | Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN | 2011-01-25 |