Artelon Convenience Kits
K-Number: K260317 · 2026-04-09
ApplicantInternational Life Sciences
Decision Date2026-04-09
Product CodeQWJ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Artelon Convenience Kits is a medical device manufactured by International Life Sciences. It received FDA 510(k) clearance on 2026-04-09 under approval number K260317. The device is classified under product code QWJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Artelon Convenience Kits?
Artelon Convenience Kits is a medical device that received FDA 510(k) clearance on 2026-04-09. It is manufactured by International Life Sciences. The 510(k) number is K260317.
When was Artelon Convenience Kits approved by the FDA?
Artelon Convenience Kits received FDA 510(k) clearance on 2026-04-09, under approval number K260317.
What company makes Artelon Convenience Kits?
Artelon Convenience Kits is manufactured by International Life Sciences.
What is the FDA product code for Artelon Convenience Kits?
The FDA product code for Artelon Convenience Kits is QWJ.
Other Devices by International Life Sciences
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.