FDA applicant

Genicon, LC

Orlando, FL6 decisions1999–200316 recalls

FDA records 6 decisions for Genicon, LC (Orlando, FL) from 1999 to 2003: 6 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HIF (Insufflator, Laparoscopic). 16 recalls are 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 Genicon, LC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Genicon, LC since 2007.

Recalls per year

1in 2020

2007high 14 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Genicon, LC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Genicon”

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

Genicon, Inc. 11

Genicon, LC

Which product codes does it file in?

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”