TrueFit Bolus
K-Number: K260308 · 2026-02-19
ApplicantAdaptiiv Medical Technologies, Inc.
Decision Date2026-02-19
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TrueFit Bolus is a medical device manufactured by Adaptiiv Medical Technologies, Inc.. It received FDA 510(k) clearance on 2026-02-19 under approval number K260308. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TrueFit Bolus?
TrueFit Bolus is a medical device that received FDA 510(k) clearance on 2026-02-19. It is manufactured by Adaptiiv Medical Technologies, Inc.. The 510(k) number is K260308.
When was TrueFit Bolus approved by the FDA?
TrueFit Bolus received FDA 510(k) clearance on 2026-02-19, under approval number K260308.
What company makes TrueFit Bolus?
TrueFit Bolus is manufactured by Adaptiiv Medical Technologies, Inc..
What is the FDA product code for TrueFit Bolus?
The FDA product code for TrueFit Bolus is MUJ.
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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.