Decision Date2026-06-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K260636. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating?
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K260636.
When did Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating receive FDA 510(k) clearance?
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260636.
Who is the listed applicant for Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating?
The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating?
The FDA product code for Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.