Company ยท US
Advanced Surgical Concepts
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2023. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2023 | K232701 | Guardenia (GAR-1) Advanced Surgical Concepts, IE | GCJ |
| Sep 17, 2021 | K211234 | RedEx Advanced Surgical Concepts, Ltd., IE | GCJ |
| Feb 25, 2020 | K192898 | PneumoLiner Advanced Surgical Concepts, IE | PMU |
| Dec 19, 2017 | DEN170075 | ContainOR Advanced Surgical Concepts, Ltd., IE | PZQ |
| Apr 7, 2016 | DEN150028 | PneumoLiner Advanced Surgical Concepts, Ltd., IE | PMU |
| Sep 6, 2012 | K121309 | ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts | OTJ |
| Jan 18, 2012 | K111407 | TRIPORT, TRIPORT+, TRIPORT15, QUADPORT Advanced Surgical Concepts | OTJ |
| Jan 26, 2011 | K110004 | ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts | OTJ |
| Nov 29, 2010 | K101794 | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA Advanced Surgical Concepts | OTJ |
| Jan 29, 2008 | K073719 | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts | GCJ |
| Dec 3, 2007 | K073170 | R-PORT II LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts | GCJ |
| Aug 23, 2007 | K070158 | R-PORT LAPAROSCOPIC ACCESS DEVICE Advanced Surgical Concepts | GCJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||