510(k) Report

FDA applicant

Domain Surgical, Inc.

Salt Lake City, UT6 decisions2011–20151 recall

FDA records 6 decisions for Domain Surgical, Inc. (Salt Lake City, UT) from 2011 to 2015: 6 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HGI (Electrocautery, Gynecologic (And Accessories)). Its devices cite 11 predicates, 5 of them its own earlier devices. 1 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 Domain Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2011: 12012: 12014: 32015: 1
2011high 3 (2014) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2011high 1 (2016) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Domain Surgical, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Domain Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories4decisions
  • HGIElectrocautery, Gynecologic (And Accessories)2decisions

Whose devices does it build on?

Its devices cite 11 predicates; 5 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 20142cite it
  • K141484Open FmsealerDomain Surgical, Inc. · 20141cites it
  • K121881Domain Surgical SystemDomain Surgical, Inc. · 20121cites it
  • K110439Domain Surgical SystemDomain Surgical, Inc. · 20111cites it

What has FDA decided for it lately?

  • K142229Laparoscopic FMsealerDomain Surgical, Inc. · 2015
  • K141484Open FmsealerDomain Surgical, Inc. · 20141 recall
  • K140384Fmwand Handpiece SEDomain Surgical, Inc. · 2014
  • K130606Fmwand Ferromagnetic Surgical SystemDomain Surgical, Inc. · 2014
  • K121881Domain Surgical SystemDomain Surgical, Inc. · 2012
  • K110439Domain Surgical SystemDomain Surgical, Inc. · 2011

All 6 as Domain Surgical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K141484FMsealer Open Shears. Model FM3001Oct 24, 2016Class II