510(k) clearances

LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated

Covidien, LLC · General, Plastic Surgery

K261070Substantially EquivalentTraditionalGEI
Open FDA's page for this record
Third party flag
N
City
Lafayette
Advisory committee description
General, Plastic Surgery
Address 1
200 Medtronic Dr.
Statement or summary
Summary
Product code
GEI
Zip code
80026
Applicant
Covidien, LLC
Decision date
2026-09-15
Decision code
SESE
Country code
US
Device name
LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
Advisory committee
SU
Contact
Marissa Miller
K number
K261070
State
CO
Date received
2026-04-01
Review advisory committee
SU
Postal code
80026
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty description
General, Plastic Surgery
Regulation number
878.4400
Device class
2
Registration number
2184009, 1221934, 3013176080, 9680952, 3003678543, 3009380063, 3009881188, 2245590, 2431166, 3006849754, 2029275, 3004111573, 2133786, 3009882464, 3013283620, 3012447612, 3007710878, 2648623, 3004122598, 3015612252, 3010280625, 1929938, 3012497308, 3009762450, 3010288205, 3012322232, 3018242561, 1836161, 2020394, 1222993, 3006891627, 9610614, 2955842, 3011879048, 3013466775, 2032098, 3004636440, 3012790575, 9614969, 3007583504 +832 more
FEI number
1221934, 3013176080, 3003678543, 3009380063, 3009881188, 2245590, 3006849754, 3004111573, 3009882464, 3013283620, 3002808445, 3012447612, 3007710878, 2648623, 3004122598, 3015612252, 3010280625, 1929938, 3012497308, 3009762450, 3010288205, 3012322232, 3018242561, 2020394, 3006891627, 1000518731, 3011879048, 1000112877, 3013466775, 1000160458, 3002900199, 1000122656, 3003186357, 3004636440, 3012790575, 3007583504, 3040335671, 3009420598, 3010164891, 3003448211 +832 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.