510(k) Report

FDA applicant

Applied Medical

Fort Worth, TX14 decisions1985–20212 recalls

FDA records 14 decisions for Applied Medical (Fort Worth, TX) from 1985 to 2021: 14 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 4 predicates, 0 of them its own earlier devices. 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 Applied Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12012: 12020: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2018

2013: 12018: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Applied Medical 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?

  • EFQGauze/Sponge, Internal6decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • GCJLaparoscope, General & Plastic Surgery1decision
  • DRCTrocar1decision
  • BTAPump, Portable, Aspiration (Manual Or Powered)1decision
  • FHFSystem, Evacuator, Fluid1decision

Also: DYB (1), DXC (1).

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K911462Surgical TrocarApplied Medical · 19911cites it
  • K122619Epix Irrigation Pump, Epix Suction Irrigation Tubing SetApplied Medical · 20121cites it
  • K003443Suction IrrigatorApplied Medical · 20011cites it
  • K070865Expanding Vascular SheathApplied Medical · 20071cites it

What has FDA decided for it lately?

  • K202818Voyant Fine Fusion Device (EB230)Applied Medical · 2021
  • K191866GelPOINT Mini Advanced Access PlatformApplied Medical · 2020
  • K122619Epix Irrigation Pump, Epix Suction Irrigation Tubing SetApplied Medical · 2012
  • K070865Expanding Vascular SheathApplied Medical · 2007
  • K003443Suction IrrigatorApplied Medical · 2001
  • K002915Flexible Occlusion SystemApplied Medical · 2001
  • K915826Bio-Polar ForcepsApplied Medical · 1992
  • K911462Surgical TrocarApplied Medical · 19912 recalls

All 14 as Applied Medical →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K9114625 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count)…Mar 12, 2018Class II
  • K911462Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.Sep 13, 2013Class II