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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Rinovum Subsidiary 2, LLC. It received FDA 510(k) clearance on 2019-01-25 under 510(k) 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. The listed applicant is Rinovum Subsidiary 2, LLC. The 510(k) number is K183468.

When did Revive Reusable Bladder Support receive FDA 510(k) clearance?

Revive Reusable Bladder Support received FDA 510(k) clearance on 2019-01-25, under 510(k) number K183468.

Who is the listed applicant for Revive Reusable Bladder Support?

The FDA 510(k) record lists Rinovum Subsidiary 2, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revive Reusable Bladder Support?

The FDA product code for Revive Reusable Bladder Support is HHW.

Related Devices (Code: HHW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage HolesCooper SurgicalK250438CooperSurgical Milex® PessariesCooperSurgical, Inc.K240798Cntrl+ Bladder Support PessaryCntrl+, Inc.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, 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.

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