510(k) Report

FDA applicant

Precision Surgical Industries, Inc.

Scotch Plains, NJ2 decisions1986–19860 recalls

FDA records 2 decisions for Precision Surgical Industries, Inc. (Scotch Plains, NJ) in 1986: 2 510(k) clearances. Most are in product codes GDX (Scalpel, One-Piece) and GDZ (Handle, Scalpel). 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 Precision Surgical Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Precision Surgical Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Precision Surgical Industries, 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?

  • GDXScalpel, One-Piece1decision
  • GDZHandle, Scalpel1decision

What has FDA decided for it lately?

  • K863950P.S.I.-Disposable Metal Handle Surgeons ScalpelPrecision Surgical Industries, Inc. · 1986
  • K863951P.S.I.-Disposable Scalpel Surgeons HandlePrecision Surgical Industries, Inc. · 1986

All 2 as Precision Surgical Industries, Inc. →