510(k) Report

FDA applicant

Prism Therapeutics, LLC

Doswell, VA1 decision1997–19970 recalls

FDA records 1 decision for Prism Therapeutics, LLC (Doswell, VA) in 1997: 1 510(k) clearance. All are in product code FED (Endoscopic Access Overtube…). 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 Prism Therapeutics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prism Therapeutics, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prism Therapeutics, LLC 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?

  • FEDEndoscopic Access Overtube, Gastroenterology-Urology1decision

What has FDA decided for it lately?

  • K972781OT-1Prism Therapeutics, LLC · 1997

The one decision as Prism Therapeutics, LLC →

Other applicant names beginning “Prism”

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

Prism Technologies, Inc. 5Prism Imaging, Inc. 4Prism Enterprises, Inc. 4Prism Clinical Imaging, Inc. 2Prism Surgical Design Pty, Ltd. 1Prism Surgical Designs Pty, Ltd. 1