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FDA 510(k)

Cntrl+ Bladder Support Pessary

K-Number: K240798 · 2024-12-17

ApplicantCntrl+, Inc.
Decision Date2024-12-17
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cntrl+ Bladder Support Pessary is the device name listed in this FDA 510(k) record. The listed applicant is Cntrl+, Inc.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K240798. 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 Cntrl+ Bladder Support Pessary?

Cntrl+ Bladder Support Pessary is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Cntrl+, Inc.. The 510(k) number is K240798.

When did Cntrl+ Bladder Support Pessary receive FDA 510(k) clearance?

Cntrl+ Bladder Support Pessary received FDA 510(k) clearance on 2024-12-17, under 510(k) number K240798.

Who is the listed applicant for Cntrl+ Bladder Support Pessary?

The FDA 510(k) record lists Cntrl+, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cntrl+ Bladder Support Pessary?

The FDA product code for Cntrl+ Bladder Support Pessary 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.K232677Reia pessaryReia, LLCK232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc.K233548Uresta®Resilia, Inc.K231786Gynethotics™ PessaryCosm Medical

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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