Sleeved IC
K-Number: K220667 · 2022-12-08
ApplicantHollister Incorporated
Decision Date2022-12-08
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Sleeved IC is a medical device manufactured by Hollister Incorporated. It received FDA 510(k) clearance on 2022-12-08 under approval number K220667. 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 Sleeved IC?
Sleeved IC is a medical device that received FDA 510(k) clearance on 2022-12-08. It is manufactured by Hollister Incorporated. The 510(k) number is K220667.
When was Sleeved IC approved by the FDA?
Sleeved IC received FDA 510(k) clearance on 2022-12-08, under approval number K220667.
What company makes Sleeved IC?
Sleeved IC is manufactured by Hollister Incorporated.
What is the FDA product code for Sleeved IC?
The FDA product code for Sleeved IC 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.