Coaptium Connect with Tissium Light
K-Number: K251957 · 2025-09-08
ApplicantTissium SA
Decision Date2025-09-08
Product CodeSFD
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Coaptium Connect with Tissium Light is a medical device manufactured by Tissium SA. It received FDA 510(k) clearance on 2025-09-08 under approval number K251957. The device is classified under product code SFD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Coaptium Connect with Tissium Light?
Coaptium Connect with Tissium Light is a medical device that received FDA 510(k) clearance on 2025-09-08. It is manufactured by Tissium SA. The 510(k) number is K251957.
When was Coaptium Connect with Tissium Light approved by the FDA?
Coaptium Connect with Tissium Light received FDA 510(k) clearance on 2025-09-08, under approval number K251957.
What company makes Coaptium Connect with Tissium Light?
Coaptium Connect with Tissium Light is manufactured by Tissium SA.
What is the FDA product code for Coaptium Connect with Tissium Light?
The FDA product code for Coaptium Connect with Tissium Light is SFD.
Other Devices by Tissium SA
Related Devices (Code: SFD)
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.