510(k) Report

FDA applicant

Justright Surgical, LLC

Newbury, NH3 decisions2013–20162 recalls

FDA records 3 decisions for Justright Surgical, LLC (Newbury, NH) from 2013 to 2016: 3 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GDW (Staple, Implantable). Its devices cite 8 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Justright Surgical”.

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 Justright Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2013: 12014: 12016: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

2in 2014

2014: 2
2013high 2 (2014) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Justright Surgical, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • GDWStaple, Implantable1decision

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 4 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.

  • K160602JustRight Surgical Vessel Sealing SystemJustright Surgical · 20163cite it
  • K123662The Justright Surgical Vessel Sealing SystemJustright Surgical, LLC · 20131cites it

What has FDA decided for it lately?

  • K160602JustRight Surgical Vessel Sealing SystemJustright Surgical · 2016
  • K132472Justright 5MM Stapler, Justright 5MM ReloadJustright Surgical, LLC · 20142 recalls
  • K123662The Justright Surgical Vessel Sealing SystemJustright Surgical, LLC · 2013

All 2 as Justright Surgical, LLC →The one decision as Justright Surgical →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K132472Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only…Aug 27, 2014Class II
  • K132472Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a…Aug 27, 2014Class II