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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

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

FDA 510(k) source

510(k) number
K261070
Applicant
Covidien, LLC
Decision date
Sep 15, 2026
Date received
Apr 1, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
GEI
Device type
Electrosurgical, Cutting & Coagulation & Accessories
Device class
Class II
Regulation
21 CFR 878.4400
Advisory committee
General, Plastic Surgery
Statement or summary
Summary
Third party
N
Location
Lafayette, CO, US