Revive Reusable Bladder Support
K-Number: K183468 · 2019-01-25
ApplicantRinovum Subsidiary 2, LLC
Decision Date2019-01-25
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Revive Reusable Bladder Support is a medical device manufactured by Rinovum Subsidiary 2, LLC. It received FDA 510(k) clearance on 2019-01-25 under approval number K183468. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Revive Reusable Bladder Support?
Revive Reusable Bladder Support is a medical device that received FDA 510(k) clearance on 2019-01-25. It is manufactured by Rinovum Subsidiary 2, LLC. The 510(k) number is K183468.
When was Revive Reusable Bladder Support approved by the FDA?
Revive Reusable Bladder Support received FDA 510(k) clearance on 2019-01-25, under approval number K183468.
What company makes Revive Reusable Bladder Support?
Revive Reusable Bladder Support is manufactured by Rinovum Subsidiary 2, LLC.
What is the FDA product code for Revive Reusable Bladder Support?
The FDA product code for Revive Reusable Bladder Support is HHW.
Related Clinical Trials
NCT04668326
Mobile Manual Standing Wheelchair for SCI
COMPLETED
NCT07355400
Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances
RECRUITING
NCT05500066
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
ENROLLING_BY_INVITATION
Related Devices (Code: HHW)
K153422Panpac Disposable Pessary Fitting SetPanpac Medical Corporation
K173351Panpac Flexi Shelf PessaryPanpac Medical Corporation
K190277ProVate Vaginal SupportContipi Medical , Ltd.
K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.
K232677Reia pessaryReia, LLC
K232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.
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.