SImmetry+ System
K-Number: K250647 · 2025-07-29
ApplicantSivantage
Decision Date2025-07-29
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SImmetry+ System is a medical device manufactured by Sivantage. It received FDA 510(k) clearance on 2025-07-29 under approval number K250647. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SImmetry+ System?
SImmetry+ System is a medical device that received FDA 510(k) clearance on 2025-07-29. It is manufactured by Sivantage. The 510(k) number is K250647.
When was SImmetry+ System approved by the FDA?
SImmetry+ System received FDA 510(k) clearance on 2025-07-29, under approval number K250647.
What company makes SImmetry+ System?
SImmetry+ System is manufactured by Sivantage.
What is the FDA product code for SImmetry+ System?
The FDA product code for SImmetry+ System is OUR.
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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.