Rejoyn
K-Number: K231209 · 2024-03-30
ApplicantOtsuka America Pharmaceutical, Inc.
Decision Date2024-03-30
Product CodeSAP
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Rejoyn is a medical device manufactured by Otsuka America Pharmaceutical, Inc.. It received FDA 510(k) clearance on 2024-03-30 under approval number K231209. The device is classified under product code SAP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Rejoyn?
Rejoyn is a medical device that received FDA 510(k) clearance on 2024-03-30. It is manufactured by Otsuka America Pharmaceutical, Inc.. The 510(k) number is K231209.
When was Rejoyn approved by the FDA?
Rejoyn received FDA 510(k) clearance on 2024-03-30, under approval number K231209.
What company makes Rejoyn?
Rejoyn is manufactured by Otsuka America Pharmaceutical, Inc..
What is the FDA product code for Rejoyn?
The FDA product code for Rejoyn is SAP.
Other Devices by Otsuka America Pharmaceutical, Inc.
Related Devices (Code: SAP)
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.