510(k) Report

FDA applicant

Flexbar Machine Corp.

Sound Beach, NY2 decisions2011–20130 recalls

FDA records 2 decisions for Flexbar Machine Corp. (Sound Beach, NY) from 2011 to 2013: 2 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Flexbar Machine Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 12013: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Flexbar Machine Corp. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K123728Retrieval BagFlexbar Machine Corp. · 20131cites it

What has FDA decided for it lately?

  • K123728Retrieval BagFlexbar Machine Corp. · 2013
  • K103840Curved / Straight / Mini / Hook Scissor Tip, Dissector Tip, Surgical HandleFlexbar Machine Corp. · 2011

All 2 as Flexbar Machine Corp. →