VENX REVOLUTION
FDA 510(k) clearance K110355 · decided 2011-04-22
Clearance details
- K-number
- K110355
- Device name
- VENX REVOLUTION
- Applicant
- Venx, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-02-07
- Decision date
- 2011-04-22
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- GAH
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| ARACHNOPHLEBECTOMY NEEDLE (K000932) | Advanced Medical Products, Inc. | 2000-05-17 |
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| RAPID FIRE HAIR IMPLANTER CAROUSEL (K972918) | Apex Medical Products, LLC | 1997-10-27 |
| NAVIGATOR (STYLET) 2006 (K972521) | Sil-Med Corp. | 1997-10-01 |
| CALVITRON HAIR TRANSPLANT SYSTEM (K952737) | Medicamat S.A. | 1995-10-03 |
| HAIR TRANSPLANT PUNCH, MULTIPLH (K770970) | Padgett Instruments, Inc. | 1977-10-27 |
Recalls involving this device
No recalls on record reference this clearance.