FirstFit Surgical Kit
K-Number: K240763 · 2024-12-18
ApplicantFreudenberg Medical, LLC
Decision Date2024-12-18
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
FirstFit Surgical Kit is a medical device manufactured by Freudenberg Medical, LLC. It received FDA 510(k) clearance on 2024-12-18 under approval number K240763. The device is classified under product code EWL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FirstFit Surgical Kit?
FirstFit Surgical Kit is a medical device that received FDA 510(k) clearance on 2024-12-18. It is manufactured by Freudenberg Medical, LLC. The 510(k) number is K240763.
When was FirstFit Surgical Kit approved by the FDA?
FirstFit Surgical Kit received FDA 510(k) clearance on 2024-12-18, under approval number K240763.
What company makes FirstFit Surgical Kit?
FirstFit Surgical Kit is manufactured by Freudenberg Medical, LLC.
What is the FDA product code for FirstFit Surgical Kit?
The FDA product code for FirstFit Surgical Kit is EWL.
Other Devices by Freudenberg Medical, LLC
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.