FDA applicant

Biopsys Medical, Inc.

San Juan Capistrano, CA15 decisions1994–19970 recalls

FDA records 15 decisions for Biopsys Medical, Inc. (San Juan Capistrano, CA) from 1994 to 1997: 15 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and GDW (Staple, Implantable). 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 Biopsys Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biopsys Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Biopsys Medical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?