510(k) Report

FDA applicant

E Surgical, LLC

Boulder, CO5 decisions2006–20240 recalls

FDA records 5 decisions for E Surgical, LLC (Boulder, CO) from 2006 to 2024: 5 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HRX (Arthroscope). Its devices cite 6 predicates, 1 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 E Surgical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 12023: 12024: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — E Surgical, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like E Surgical, LLC’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
  • HRXArthroscope1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K231126Eblator DeviceE Surgical, LLC · 20231cites it
  • K060255E Surgical Electrosurgical Patient Return Electrode, Dual Plate with Cord and Electrosurgical Patient Return…E Surgical, LLC · 20061cites it

What has FDA decided for it lately?

  • K233115Hawkeye Control Unit with Eyas EndoscopeE Surgical, LLC · 2024
  • K231126Eblator DeviceE Surgical, LLC · 2023
  • K071080Electrosurgical Infant Patient Return Electrode, Dual Plate with Cord, Model EP 211ME Surgical, LLC · 2007
  • K061878Electrode Coated Ball, Model AB302C; Needle, Model AN301C; Blade, Model AE301HCE Surgical, LLC · 2006
  • K060255E Surgical Electrosurgical Patient Return Electrode, Dual Plate with Cord and Electrosurgical Patient Return…E Surgical, LLC · 2006

All 5 as E Surgical, LLC →