CurvaFix IM System
K-Number: K222505 · 2022-10-27
ApplicantCurvafix, Inc.
Decision Date2022-10-27
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CurvaFix IM System is a medical device manufactured by Curvafix, Inc.. It received FDA 510(k) clearance on 2022-10-27 under approval number K222505. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CurvaFix IM System?
CurvaFix IM System is a medical device that received FDA 510(k) clearance on 2022-10-27. It is manufactured by Curvafix, Inc.. The 510(k) number is K222505.
When was CurvaFix IM System approved by the FDA?
CurvaFix IM System received FDA 510(k) clearance on 2022-10-27, under approval number K222505.
What company makes CurvaFix IM System?
CurvaFix IM System is manufactured by Curvafix, Inc..
What is the FDA product code for CurvaFix IM System?
The FDA product code for CurvaFix IM System is HWC. This falls under the Cardiovascular category.
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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.