Advanced Surgical Concepts, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K232701 | Guardenia (GAR-1) | September 29, 2023 |
| K211234 | RedEx | September 17, 2021 |
| K192898 | PneumoLiner | February 25, 2020 |
| DEN170075 | ContainOR | December 19, 2017 |
| DEN150028 | PneumoLiner | April 7, 2016 |
| K121309 | ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE | September 6, 2012 |
| K111407 | TRIPORT, TRIPORT+, TRIPORT15, QUADPORT | January 18, 2012 |
| K110004 | ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE | January 26, 2011 |
| K101794 | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCES | November 29, 2010 |
| K073719 | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE | January 29, 2008 |
| K073170 | R-PORT II LAPAROSCOPIC ACCESS DEVICE | December 3, 2007 |
| K070158 | R-PORT LAPAROSCOPIC ACCESS DEVICE | August 23, 2007 |