510(k) Report

FDA applicant

Physion, Inc.

Short Hills, NJ2 decisions2003–20050 recalls

FDA records 2 decisions for Physion, Inc. (Short Hills, NJ) from 2003 to 2005: 2 510(k) clearances. Most are in product codes EGJ (Device, Iontophoresis, Other Uses) and FBK (Endoscopic Injection Needle…). 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Physion, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Physion, 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?

  • EGJDevice, Iontophoresis, Other Uses1decision
  • FBKEndoscopic Injection Needle, Gastroenterology-Urology1decision

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.

  • K043383N-DO Endoinjector Needle, Model PH00961109 and PH00961110Physion, Inc. · 20051cites it

What has FDA decided for it lately?

  • K043383N-DO Endoinjector Needle, Model PH00961109 and PH00961110Physion, Inc. · 2005
  • K022950Miniphysionizer 2.0 and ElectrodesPhysion, Inc. · 2003

All 2 as Physion, Inc. →