FDA applicant

Envis, Inc.

Asheville, NC1 decision1999–19990 recalls

FDA records 1 decision for Envis, Inc. (Asheville, NC) in 1999: 1 510(k) clearance. All are in product code LRD (Applicator, Ent Drug). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Envis, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Envis, Inc.’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

Envis, Inc.

Which product codes does it file in?

What has FDA decided for it lately?