510(k) Report

FDA applicant

Padgett Instruments, Inc.

Kansas City, MO2 decisions1977–19950 recalls

FDA records 2 decisions for Padgett Instruments, Inc. (Kansas City, MO) from 1977 to 1995: 2 510(k) clearances. Most are in product codes GFD (Dermatome) and GAH (Stylet, Surgical, General & Plastic Surgery). 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 Padgett Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Padgett Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Padgett Instruments, 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?

  • GFDDermatome1decision
  • GAHStylet, Surgical, General & Plastic Surgery1decision

What has FDA decided for it lately?

  • K951085Padgett Air Dermatome, Model aPadgett Instruments, Inc. · 1995
  • K770970Hair Transplant Punch, MultiplhPadgett Instruments, Inc. · 1977

All 2 as Padgett Instruments, Inc. →