510(k) Report

FDA applicant

August C. Stiefel Research Institute, Inc.

Oakhill, NY1 decision1985–19850 recalls

FDA records 1 decision for August C. Stiefel Research Institute, Inc. (Oakhill, NY) in 1985: 1 510(k) clearance. All are in product code FCI (Punch, Biopsy). 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 August C. Stiefel Research Institute, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for August C. Stiefel Research Institute, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • FCIPunch, Biopsy1decision

What has FDA decided for it lately?

  • K853104Disposable, Sterile Biopsy PunchAugust C. Stiefel Research Institute, Inc. · 1985

The one decision as August C. Stiefel Research Institute, Inc. →