510(k) Report

FDA applicant

Cush Industries, Inc.

Piney Flats, TN1 decision1994–19940 recalls

FDA records 1 decision for Cush Industries, Inc. (Piney Flats, TN) in 1994: 1 510(k) clearance. All are in product code KKX (Drape, Surgical, Antimicrobial). 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, general and plastic surgery panel, where it files most

How often FDA has decided Cush Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cush Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cush Industries, 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 “Cush”

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