Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
FDA 510(k) clearance K160754 · decided 2016-09-09
Clearance details
- K-number
- K160754
- Device name
- Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
- Applicant
- Venclose, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-18
- Decision date
- 2016-09-09
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal recall (Z-2638-2025) | Bard Peripheral Vascular Inc | 2025-09-26 |
| The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radio recall (Z-0371-2025) | Bard Peripheral Vascular Inc | 2024-11-13 |