510(k) Report

FDA applicant

Laurimed, LLC

Redwood City, CA8 decisions2008–20171 recall

FDA records 8 decisions for Laurimed, LLC (Redwood City, CA) from 2008 to 2017: 8 510(k) clearances. Most are in product codes ERL (Drill, Surgical, Ent (Electric Or Pneumatic)…) and BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)). Its devices cite 13 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, ear, nose and throat panel, where it files most

How often FDA has decided Laurimed, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008: 22009: 32013: 12016: 12017: 1
2008high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2008high 1 (2014) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Laurimed, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Laurimed, 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?

  • ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece3decisions
  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)3decisions
  • HRXArthroscope2decisions

Whose devices does it build on?

Its devices cite 13 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.

  • K133133Laurimed Polypvac MicrodebriderLaurimed, LLC · 20131cites it
  • K083909Spinal Injection SystemLaurimed, LLC · 20091cites it
  • K080140Laurimed Spinal Injection SystemLaurimed, LLC · 20081cites it
  • K082194Laurimed Percutaneous Discectomy System, Model FG-000002Laurimed, LLC · 20081cites it
  • K161101PolypVac Microdebrider (3.3mm and 4.0mm)Laurimed, LLC · 20161cites it

What has FDA decided for it lately?

  • K1632473.3 mm Laurimed Microdebrider; 4.0 mm Laurimed MicrodebriderLaurimed, LLC · 2017
  • K161101PolypVac Microdebrider (3.3mm and 4.0mm)Laurimed, LLC · 2016
  • K133133Laurimed Polypvac MicrodebriderLaurimed, LLC · 20131 recall
  • K091818Laurimed Spinal Injection SystemLaurimed, LLC · 2009
  • K090815Percutaneous Discectomy SystemLaurimed, LLC · 2009
  • K083909Spinal Injection SystemLaurimed, LLC · 2009
  • K082194Laurimed Percutaneous Discectomy System, Model FG-000002Laurimed, LLC · 2008
  • K080140Laurimed Spinal Injection SystemLaurimed, LLC · 2008

All 8 as Laurimed, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K133133PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1…Apr 7, 2014Class III