510(k) Report

FDA applicant

Onux Medical, Inc.

Hampton, NH5 decisions2001–20020 recalls

FDA records 5 decisions for Onux Medical, Inc. (Hampton, NH) from 2001 to 2002: 5 510(k) clearances. Most are in product codes GDW (Staple, Implantable) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Onux Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Onux Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Onux Medical, 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?

  • GDWStaple, Implantable2decisions
  • GCJLaparoscope, General & Plastic Surgery1decision
  • NJUSuture, Nonabsorbable, Nitinol1decision
  • GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K003522SaluteOnux Medical, Inc. · 20011cites it
  • K023372Non-Bioabsorbable StapleOnux Medical, Inc. · 20021cites it

What has FDA decided for it lately?

  • K023372Non-Bioabsorbable StapleOnux Medical, Inc. · 2002
  • K022777Manual Touche SystemOnux Medical, Inc. · 2002
  • K014286Salute, Model 3022Onux Medical, Inc. · 2002
  • K010620Endoscopic Staple Removal InstrumentOnux Medical, Inc. · 2001
  • K003522SaluteOnux Medical, Inc. · 2001

All 5 as Onux Medical, Inc. →