510(k) Report

FDA applicant

Top Corp.

Dunwoody, GA4 decisions1986–20190 recalls

FDA records 4 decisions for Top Corp. (Dunwoody, GA) from 1986 to 2019: 4 510(k) clearances. Most are in product codes GXI (Probe, Radiofrequency Lesion) and FMF (Syringe, Piston). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Top Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

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

FDA decisions per year

1in 2019

2007: 12008: 12019: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Top Corp. 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?

  • GXIProbe, Radiofrequency Lesion2decisions
  • FMFSyringe, Piston1decision
  • FIENeedle, Fistula1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K062946Top Neuropole Needles, Models ST, X, RC, XE and TLTop Corp. · 20072cite it
  • K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 20081cites it

What has FDA decided for it lately?

  • K1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip…Top Corporation · 2019
  • K080771Top Neuropole Needle, Model SH, BL, SC, TCTop Corp. · 2008
  • K062946Top Neuropole Needles, Models ST, X, RC, XE and TLTop Corp. · 2007
  • K860449Modification Top Ultra Thinwall a-V Fistula NeedleTop Corp. · 1986

All 3 as Top Corp. →The one decision as Top Corporation →