510(k) K132974
- Device
- AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR
- Applicant
- MEDTRONIC ADVANCED ENERGY, LLC
- 510(k) number
- K132974
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-03
- Date received
- 2013-09-23
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GABRIELA ANCHONDO
- Address
- 180 International Dr. Portsmouth NH US 03801 03801
FDA Registration Numbers#
- 2084346
- 2523676
- 3016050940
- 3007499195
- 3044464950
- 3029895042
- 3005099803
- 3013438730
- 3018242561
- 1422634
- 2242056
- 3010621964
- 2020550
- 9680718
- 3015895045
- 9611102
- 3010739934
- 1836161
- 3008868758
- 1721194
- 3033511105
- 3043585137
- 2024311
- 9611503
- 2936485
- 1423662
- 8044091
- 2184009
- 3026612481
- 9681383
- 3005857264
- 3009051888
- 3022327202
- 1820334
- 1526012
- 3024712917
- 2244478
- 3012329552
- 3016904853
- 2954354
- 3010069773
- 3008573567
- 3020468145
- 1000121056
- 2529846
- 2938071
- 3013551587
- 3040004547
- 3007675948
- 1056553
- 2518897
- 3012204368
- 3032109
- 3001431138
- 1032347
- 2027111
- 9614434
- 1423714
- 1054241
- 9610877
- 3010952064
- 3013917867
- 8043548
- 3004105270
- 3013111980
- 3010653929
- 3006554912
- 3008933393
- 2650143
- 9710649
- 1018470
- 3012510750
- 3012606445
- 3020163307
- 3011706110
- 1018233
- 3016851379
- 3009905888
- 2183870
Source Documents#
Other 510(k) Records For Product Code GEI #
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|---|---|---|---|
| K253504 | Volnewmer™ | Classys, Inc. | 2026-07-13 |
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| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2026-06-29 |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | 2026-06-29 |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | 2026-06-18 |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2026-06-16 |
| K253165 | LAP-iX2N | Sejong Medical Co., Ltd. | 2026-06-09 |
| K253656 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | 2026-06-05 |
| K253803 | MILAN System | Lumenis Be, Ltd. | 2026-06-02 |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | 2026-06-02 |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | 2026-05-29 |
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | 2026-05-26 |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | 2026-05-20 |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | 2026-05-18 |
Legacy Summary#
summary
FDA Review#
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