FDA applicant
Fujinon, Inc.
FDA records 30 decisions for Fujinon, Inc. (New York, NY) from 1990 to 2012: 30 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FDS (Gastroscope And Accessories, Flexible/Rigid). Its devices cite 22 predicates, 14 of them its own earlier devices. 12 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fujinon, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2012
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Fujinon, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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