Encore System
K-Number: K213159 · 2021-12-22
ApplicantSiesta Medical, Inc.
Decision Date2021-12-22
Product CodeORY
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Encore System is a medical device manufactured by Siesta Medical, Inc.. It received FDA 510(k) clearance on 2021-12-22 under approval number K213159. The device is classified under product code ORY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Encore System?
Encore System is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Siesta Medical, Inc.. The 510(k) number is K213159.
When was Encore System approved by the FDA?
Encore System received FDA 510(k) clearance on 2021-12-22, under approval number K213159.
What company makes Encore System?
Encore System is manufactured by Siesta Medical, Inc..
What is the FDA product code for Encore System?
The FDA product code for Encore System is ORY.
Other Devices by Siesta Medical, Inc.
Related Devices (Code: ORY)
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.