510(k) Report

FDA applicant

N-S Medical Products

Gainesville, FL5 decisions1987–19882 recalls

FDA records 5 decisions for N-S Medical Products (Gainesville, FL) from 1987 to 1988: 5 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and KNW (Instrument, Biopsy). 2 recalls are linked to its devices.

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

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

How often FDA has decided N-S Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for N-S Medical Products since 2007.

Recalls per year

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — N-S Medical Products 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?

  • DQXWire, Guide, Catheter2decisions
  • KNWInstrument, Biopsy2decisions
  • GDMNeedle, Aspiration And Injection, Reusable1decision

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.

  • K881957Hawkins-Akins Blunt Needle Access KitN-S Medical Products · 19881cites it

What has FDA decided for it lately?

  • K880287Tru-Trac Coiled GuidewireN-S Medical Products · 1988
  • K880288Tru-Trac Torque GuidewireN-S Medical Products · 1988
  • K881957Hawkins-Akins Blunt Needle Access KitN-S Medical Products · 19881 recall
  • K881956National-Standard Needle HolderN-S Medical Products · 1988
  • K870523Hawkins Breast Localization NeedleN-S Medical Products · 19871 recall

All 5 as N-S Medical Products →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K881957Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057…Sep 1, 2009
  • K870523Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening…Sep 1, 2009