510(k) Report

FDA applicant

Tridak Division of Indicon, Inc.

Pearl River, NY7 decisions1984–19900 recalls

FDA records 7 decisions for Tridak Division of Indicon, Inc. (Pearl River, NY) from 1984 to 1990: 7 510(k) clearances. Most are in product codes FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic…) and FCW (Light Source, Fiberoptic, Routine). 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 Tridak Division of Indicon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tridak Division of Indicon, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Tridak”

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