510(k) Report

FDA applicant

Innovative Surgical Technology, Inc.

Los Alamos, NM1 decision1993–19931 recall

FDA records 1 decision for Innovative Surgical Technology, Inc. (Los Alamos, NM) in 1993: 1 510(k) clearance. All are in product code GES (Blade, Scalpel). 1 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 Innovative Surgical Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innovative Surgical Technology, Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Innovative Surgical Technology, 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?

  • GESBlade, Scalpel1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K923170Los Alamos Retractable KnifeInnovative Surgical Technology, Inc. · 19931cites it

What has FDA decided for it lately?

  • K923170Los Alamos Retractable KnifeInnovative Surgical Technology, Inc. · 19931 recall

The one decision as Innovative Surgical Technology, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K923170Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No…Sep 29, 2009