510(k) K110355
K110355 is an FDA 510(k) premarket notification submitted by Venx, LLC for the device "VENX REVOLUTION". The FDA issued a decision of Substantially Equivalent on April 22, 2011. The device falls under product code GAH (Stylet, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2011
- Date Received
- February 7, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stylet, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type