510(k) Report

FDA applicant

Percuvision, LLC

Gahanna, OH3 decisions2009–20110 recalls

FDA records 3 decisions for Percuvision, LLC (Gahanna, OH) from 2009 to 2011: 3 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and FGC (Urethroscope). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Percuvision”.

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 Percuvision, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2009: 22011: 1
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Percuvision, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EZLCatheter, Retention Type, Balloon2decisions
  • FGCUrethroscope1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K090262Percucath Urinary CatheterPercuvision, LLC · 20091cites it

What has FDA decided for it lately?

  • K110214Directvision Catheter, UncoatedPercuvision · 2011
  • K091600Directvision Guide SystemPercuvision, LLC · 2009
  • K090262Percucath Urinary CatheterPercuvision, LLC · 2009

All 2 as Percuvision, LLC →The one decision as Percuvision →