510(k) Report

FDA applicant

Medtronic Advanced Energy

Portsmouth, NH11 decisions2012–20190 recalls

FDA records 11 decisions for Medtronic Advanced Energy (Portsmouth, NH) from 2012 to 2019: 11 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and LPH (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 148 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medtronic Advanced Energy, LLC”.

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 Medtronic Advanced Energy’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2012: 12013: 22014: 12015: 12016: 12017: 32018: 12019: 1
2012high 3 (2017) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Medtronic Advanced Energy by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medtronic Advanced Energy’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 & Accessories10decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 148 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 25 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 5 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.

  • K132974Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0…Medtronic Advanced Energy, LLC · 20134cite it
  • K120909EC 2.7 Endoscopic CutterMedtronic Advanced Energy, LLC · 20122cite it
  • K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy · 20141cites it
  • K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy · 20181cites it

What has FDA decided for it lately?

  • K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy · 2019
  • K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0Medtronic Advanced Energy · 2018
  • K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex MiniMedtronic Advanced Energy · 2017
  • K170610PlasmaBlade TMedtronic Advanced Energy · 2017
  • K170296CoreCath 2.7SMedtronic Advanced Energy · 2017
  • K152703PlasmaBlade TnA Tonsil and Adenoid Dissection DeviceMedtronic Advanced Energy · 2016
  • K150297PlasmaBlade UPPP and Suction CoagulatorMedtronic Advanced Energy · 2015
  • K143175AEx Generator; PlasmaBlade TMedtronic Advanced Energy · 2014

All 8 as Medtronic Advanced Energy →All 3 as Medtronic Advanced Energy, LLC →