510(k) Report

FDA applicant

Assured Surgical Products, Inc.

San Bernardino, CA2 decisions1992–19920 recalls

FDA records 2 decisions for Assured Surgical Products, Inc. (San Bernardino, CA) in 1992: 2 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FYA (Gown, Surgical). 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 Assured Surgical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Assured Surgical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Assured Surgical Products, 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?

  • KKXDrape, Surgical, Antimicrobial1decision
  • FYAGown, Surgical1decision

What has FDA decided for it lately?

  • K914605Multiple Sterile Surgical Drape PackAssured Surgical Products, Inc. · 1992
  • K914563Sterile Sugical Gown PackAssured Surgical Products, Inc. · 1992

All 2 as Assured Surgical Products, Inc. →

Other applicant names beginning “Assured”

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

Assured Sound Laboratories, Inc. 1Assured Medical Supply Co., Ltd. 1