510(k) DEN110016
DEN110016 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery for the device "PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS". The FDA issued a decision of De Novo Granted on April 30, 2012. The device falls under product code OXT (Percutaneous Surgical Set With Attachments), a Class II device regulated under 21 CFR 878.4805. Ethicon Endo-Surgery has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 30, 2012
- Date Received
- September 21, 2011
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percutaneous Surgical Set With Attachments
- Device Class
- Class II
- Regulation Number
- 878.4805
- Review Panel
- SU
- Submission Type
Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues.