510(k) Report

FDA applicant

Gibbons Surgical Corp.

Virginia Beach, VA2 decisions2001–20010 recalls

FDA records 2 decisions for Gibbons Surgical Corp. (Virginia Beach, VA) in 2001: 2 510(k) clearances. Most are in product codes FHO (Pneumoperitoneum Needle) and FBQ (Trocar, Gastro-Urology). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Gibbons Surgical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gibbons Surgical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gibbons Surgical Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FHOPneumoperitoneum Needle1decision
  • FBQTrocar, Gastro-Urology1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K012198Gibbons Sterile Trocar KitsGibbons Surgical Corp. · 20011cites it

What has FDA decided for it lately?

  • K012198Gibbons Sterile Trocar KitsGibbons Surgical Corp. · 2001
  • K010779Modification to:Laparoscopic/Endoscopic InstrumentGibbons Surgical Corp. · 2001

All 2 as Gibbons Surgical Corp. →