510(k) Report

FDA applicant

Injectx, Inc.

San Jose, CA1 decision2001–20010 recalls

FDA records 1 decision for Injectx, Inc. (San Jose, CA) in 2001: 1 510(k) clearance. All are in product code FTL (Mesh, Surgical, Polymeric). 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 Injectx, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Injectx, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Injectx, 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?

  • FTLMesh, Surgical, Polymeric1decision

Who builds on its devices?

Later devices cite its devices 5 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.

  • K010533Biosling - Bioabsorbable Polymer Sling & Surgical MeshInjectx, Inc. · 20015cite it

What has FDA decided for it lately?

  • K010533Biosling - Bioabsorbable Polymer Sling & Surgical MeshInjectx, Inc. · 2001

The one decision as Injectx, Inc. →