SteriStay
K-Number: K190027 · 2019-05-10
ApplicantToul Meditech AB
Decision Date2019-05-10
Product CodeORC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SteriStay is a medical device manufactured by Toul Meditech AB. It received FDA 510(k) clearance on 2019-05-10 under approval number K190027. The device is classified under product code ORC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SteriStay?
SteriStay is a medical device that received FDA 510(k) clearance on 2019-05-10. It is manufactured by Toul Meditech AB. The 510(k) number is K190027.
When was SteriStay approved by the FDA?
SteriStay received FDA 510(k) clearance on 2019-05-10, under approval number K190027.
What company makes SteriStay?
SteriStay is manufactured by Toul Meditech AB.
What is the FDA product code for SteriStay?
The FDA product code for SteriStay is ORC.
Other Devices by Toul Meditech AB
Related Devices (Code: ORC)
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.