FDA applicant

Genicon, Inc.

Winter Park, FL11 decisions2004–20193 recalls

FDA records 11 decisions for Genicon, Inc. (Winter Park, FL) from 2004 to 2019: 11 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 45 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 4 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Genicon”.

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 Genicon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007high 3 (2018) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Genicon, 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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Other applicant names beginning “Genicon”

FDA records each applicant name separately; these may or may not be the same firm.

Genicon, LC 6

Genicon, Inc.

Which product codes does it file in?

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Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Genicon”