Female IC (Not Finalized)
K-Number: K213575 · 2022-09-13
ApplicantHollister Incorporated
Decision Date2022-09-13
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Female IC (Not Finalized) is a medical device manufactured by Hollister Incorporated. It received FDA 510(k) clearance on 2022-09-13 under approval number K213575. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Female IC (Not Finalized)?
Female IC (Not Finalized) is a medical device that received FDA 510(k) clearance on 2022-09-13. It is manufactured by Hollister Incorporated. The 510(k) number is K213575.
When was Female IC (Not Finalized) approved by the FDA?
Female IC (Not Finalized) received FDA 510(k) clearance on 2022-09-13, under approval number K213575.
What company makes Female IC (Not Finalized)?
Female IC (Not Finalized) is manufactured by Hollister Incorporated.
What is the FDA product code for Female IC (Not Finalized)?
The FDA product code for Female IC (Not Finalized) is EZD.
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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.