Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IrelandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Advanced Surgical Concepts with 14 510(k) clearances. The most recent is a 510(k) clearance dated Sep 29, 2023: Guardenia (GAR-1).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 29, 2023 | Guardenia (GAR-1)K232701 · GCJ | 510(k) clearances |
| Sep 17, 2021 | RedExK211234 · GCJ | 510(k) clearances |
| Feb 25, 2020 | PneumoLinerK192898 · PMU | 510(k) clearances |
| Dec 19, 2017 | ContainORDEN170075 · PZQ | 510(k) clearances |
| Apr 7, 2016 | PneumoLinerDEN150028 · PMU | 510(k) clearances |
| Sep 6, 2012 | ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICEK121309 · OTJ | 510(k) clearances |
| Jan 18, 2012 | TRIPORT, TRIPORT+, TRIPORT15, QUADPORTK111407 · OTJ | 510(k) clearances |
| Jan 26, 2011 | ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICEK110004 · OTJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
