510(k) Report

FDA applicant

The Microoptical Corporation

North Attleboro, MA2 decisions2004–20040 recalls

FDA records 2 decisions for The Microoptical Corporation (North Attleboro, MA) in 2004: 2 510(k) clearances. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 3 predicates, 1 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 The Microoptical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Microoptical Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — The Microoptical Corporation 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?

  • GCJLaparoscope, General & Plastic Surgery2decisions

Whose devices does it build on?

Its devices cite 3 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.

  • K040244Microoptical's Critical Data Viewers, Models MD-3 and MD-6The Microoptical Corporation · 20041cites it

What has FDA decided for it lately?

  • K042923MD-6W Wireless Critical Data ViewerThe Microoptical Corporation · 2004
  • K040244Microoptical's Critical Data Viewers, Models MD-3 and MD-6The Microoptical Corporation · 2004

All 2 as The Microoptical Corporation →