Sim&Size
K-Number: K253122 · 2025-12-23
ApplicantSim&Cure
Decision Date2025-12-23
Product CodePZO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Sim&Size is a medical device manufactured by Sim&Cure. It received FDA 510(k) clearance on 2025-12-23 under approval number K253122. The device is classified under product code PZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sim&Size?
Sim&Size is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Sim&Cure. The 510(k) number is K253122.
When was Sim&Size approved by the FDA?
Sim&Size received FDA 510(k) clearance on 2025-12-23, under approval number K253122.
What company makes Sim&Size?
Sim&Size is manufactured by Sim&Cure.
What is the FDA product code for Sim&Size?
The FDA product code for Sim&Size is PZO.
Other Devices by Sim&Cure
Related Devices (Code: PZO)
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.