Company ยท US
Medtronic Advanced Energy, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2019. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 2019 | K183129 | Medtronic Total Hip Arthroplasty System Medtronic Advanced Energy | LPH |
| Aug 2, 2018 | K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 Medtronic Advanced Energy | GEI |
| Sep 7, 2017 | K170381 | Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini Medtronic Advanced Energy | GEI |
| Apr 13, 2017 | K170610 | PlasmaBlade T Medtronic Advanced Energy | GEI |
| Mar 20, 2017 | K170296 | CoreCath 2.7S Medtronic Advanced Energy | GEI |
| Jul 8, 2016 | K152703 | PlasmaBlade TnA Tonsil and Adenoid Dissection Device Medtronic Advanced Energy | GEI |
| May 21, 2015 | K150297 | PlasmaBlade UPPP and Suction Coagulator Medtronic Advanced Energy | GEI |
| Dec 31, 2014 | K143175 | AEx Generator; PlasmaBlade T Medtronic Advanced Energy | GEI |
| Dec 3, 2013 | K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR Medtronic Advanced Energy, LLC | GEI |
| Jan 10, 2013 | K123201 | AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER Medtronic Advanced Energy, LLC | GEI |
| Nov 2, 2012 | K120909 | EC 2.7 ENDOSCOPIC CUTTER Medtronic Advanced Energy, LLC | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
900-130: 5 Pack 30mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | K003190 |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-120BT: 5 Pack 20mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examinati Terminated |
KNW | K003190 |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-120: 5 Pack 20mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | K003190 |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
900-120: 5 Pack 20mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | K003190 |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-115BT: 5 Pack 15mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examinati Terminated |
KNW | K003190 |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-115: 5 Pack 15mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | K003190 |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
900-115: 5 Pack 15mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | K003190 |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-112BT: 5 Pack 12mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examinati Terminated |
KNW | K003190 |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-112: 5 Pack 12mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | K003190 |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
900-112: 5 Pack 12mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | K003190 |
| Feb 2, 2017 | Medtronic Advanced Energy, LLC Intact Disposable Wands (part of the Intact System)
777-110: 5 Pack 10mm Disposable
Product Usage:
The Intact Medical disposable wands are intended to provide breast tissue for histologic examination Terminated |
KNW | K003190 |
| Jan 31, 2014 | Medtronic Advanced Energy, LLC Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories)
The Aquamantys3 System combines radio frequency Terminated |
GEI | K111285 |