AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR

Electrosurgical, Cutting & Coagulation & Accessories

MEDTRONIC ADVANCED ENERGY, LLC

The following data is part of a premarket notification filed by Medtronic Advanced Energy, Llc with the FDA for Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, Sbs 5.0 Sheathed Bipolar.

Pre-market Notification Details

Device IDK132974
510k NumberK132974
Device Name:AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant MEDTRONIC ADVANCED ENERGY, LLC 180 INTERNATIONAL DRIVE Portsmouth,  NH  03801
ContactGabriela Anchondo
CorrespondentGabriela Anchondo
MEDTRONIC ADVANCED ENERGY, LLC 180 INTERNATIONAL DRIVE Portsmouth,  NH  03801
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-23
Decision Date2013-12-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169868243 K132974 000
00763000447267 K132974 000
00763000280895 K132974 000
00763000280901 K132974 000
00763000280925 K132974 000
00763000280949 K132974 000
00763000047429 K132974 000
00763000047436 K132974 000
00763000047443 K132974 000
00763000047467 K132974 000
00763000047474 K132974 000
00643169456204 K132974 000
00643169456211 K132974 000
00643169456228 K132974 000
00643169532205 K132974 000
00643169868182 K132974 000
00643169868199 K132974 000
00643169868229 K132974 000
00763000447243 K132974 000

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