UroLift System Rigid Retrieval Kit Sterilization Tray
K-Number: K212396 · 2021-10-22
ApplicantNeotract, Inc.
Decision Date2021-10-22
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
UroLift System Rigid Retrieval Kit Sterilization Tray is a medical device manufactured by Neotract, Inc.. It received FDA 510(k) clearance on 2021-10-22 under approval number K212396. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UroLift System Rigid Retrieval Kit Sterilization Tray?
UroLift System Rigid Retrieval Kit Sterilization Tray is a medical device that received FDA 510(k) clearance on 2021-10-22. It is manufactured by Neotract, Inc.. The 510(k) number is K212396.
When was UroLift System Rigid Retrieval Kit Sterilization Tray approved by the FDA?
UroLift System Rigid Retrieval Kit Sterilization Tray received FDA 510(k) clearance on 2021-10-22, under approval number K212396.
What company makes UroLift System Rigid Retrieval Kit Sterilization Tray?
UroLift System Rigid Retrieval Kit Sterilization Tray is manufactured by Neotract, Inc..
What is the FDA product code for UroLift System Rigid Retrieval Kit Sterilization Tray?
The FDA product code for UroLift System Rigid Retrieval Kit Sterilization Tray is KCT.
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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.