510(k) Report

FDA applicant

Neimark Labs, Inc.

Mission Viejo, CA2 decisions1992–19930 recalls

FDA records 2 decisions for Neimark Labs, Inc. (Mission Viejo, CA) from 1992 to 1993: 2 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HXY (Brace, Drill). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Neimark Labs, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neimark Labs, 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?

  • GCJLaparoscope, General & Plastic Surgery1decision
  • HXYBrace, Drill1decision

What has FDA decided for it lately?

  • K933536Carter-Thomason Needle-Point Suture PasserNeimark Labs, Inc. · 1993
  • K923776Benderev Drill GuideNeimark Labs, Inc. · 1992

All 2 as Neimark Labs, Inc. →