Venx Revolution
FDA 510(k) K110355 · Venx, LLC
510(k) numberK110355
Submission
- Device name
- Venx Revolution
- Applicant
- Venx, LLC
Tucson, AZ, US - Received
- February 7, 2011
- Decision date
- April 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAH – Stylet, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GAH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000932 | Arachnophlebectomy NeedleGAH · Traditional | Advanced Medical Products, Inc. | 05/17/2000SE |
| K970306 | Markman Template SystemGAH · Traditional | Barry Markman, M.D. | 11/20/1997SE |
| K972918 | Rapid Fire Hair Implanter CarouselGAH · Traditional | Apex Medical Products, LLC | 10/27/1997SE |
| K972521 | Navigator (Stylet) 2006GAH · Traditional | Sil-Med Corp. | 10/01/1997SE |
| K952737 | Calvitron Hair Transplant SystemGAH · Traditional | Medicamat S.A. | 10/03/1995SE |
| K770970 | Hair Transplant Punch, MultiplhGAH · Traditional | Padgett Instruments, Inc. | 10/27/1977SE |
Questions and answers
When was Venx Revolution cleared by the FDA?
Venx Revolution (K110355) received a 510(k) decision of Substantially Equivalent on April 22, 2011, 74 days after the submission was received.
What is the product code of K110355?
The FDA product code is GAH – Stylet, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.