DEN110016 is an FDA 510(k) submission for the PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS. This device is classified as a Percutaneous Surgical Set With Attachments (Class II - Special Controls, product code OXT).
Submitted by Ethicon Endo-Surgery (Cincinnati, US). The FDA issued a Not Cleared (DENG) decision on April 30, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4805. 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..
| 510(k) Number | DEN110016 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 21, 2011 |
| Decision Date | April 30, 2012 |
| Days to Decision | 222 days |
| Submission Type | Post-NSE |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | OXT - Percutaneous Surgical Set With Attachments |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4805 |
| Definition | 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. |