510(k) Report

FDA applicant

Vesitec Medical, Inc.

Laguna Hills, CA3 decisions1993–19942 recalls

FDA records 3 decisions for Vesitec Medical, Inc. (Laguna Hills, CA) from 1993 to 1994: 3 510(k) clearances. Most are in product codes JDR (Staple, Fixation, Bone) and KOA (Surgical Instruments, G-U, Manual (And…). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Vesitec Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vesitec Medical, 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?

  • JDRStaple, Fixation, Bone2decisions
  • KOASurgical Instruments, G-U, Manual (And Accessories)1decision

Who builds on its devices?

Later devices cite its devices 7 times; 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.

  • K932925Bone Anchor for Soft Tissue AttachmentVesitec Medical, Inc. · 19945cite it
  • K931181Vesitec Suture PasserVesitec Medical, Inc. · 19931cites it
  • K931182Vesitec Drill GuideVesitec Medical, Inc. · 19931cites it

What has FDA decided for it lately?

  • K932925Bone Anchor for Soft Tissue AttachmentVesitec Medical, Inc. · 19942 recalls
  • K931182Vesitec Drill GuideVesitec Medical, Inc. · 1993
  • K931181Vesitec Suture PasserVesitec Medical, Inc. · 1993

All 3 as Vesitec Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K932925Boston Scientific Vesica Drill-In Bone Locator; sterile, single use only; REF/Catalog…Jun 2, 2006
  • K932925Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use…Jun 2, 2006