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FDA 510(k)

Panpac Disposable Pessary Fitting Set

K-Number: K153422 · 2016-07-14

ApplicantPanpac Medical Corporation
Decision Date2016-07-14
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Panpac Disposable Pessary Fitting Set is a medical device manufactured by Panpac Medical Corporation. It received FDA 510(k) clearance on 2016-07-14 under approval number K153422. 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 Panpac Disposable Pessary Fitting Set?

Panpac Disposable Pessary Fitting Set is a medical device that received FDA 510(k) clearance on 2016-07-14. It is manufactured by Panpac Medical Corporation. The 510(k) number is K153422.

When was Panpac Disposable Pessary Fitting Set approved by the FDA?

Panpac Disposable Pessary Fitting Set received FDA 510(k) clearance on 2016-07-14, under approval number K153422.

What company makes Panpac Disposable Pessary Fitting Set?

Panpac Disposable Pessary Fitting Set is manufactured by Panpac Medical Corporation.

What is the FDA product code for Panpac Disposable Pessary Fitting Set?

The FDA product code for Panpac Disposable Pessary Fitting Set is HHW.

Related Clinical Trials

NCT07554651 Cross-Shaped Vaginal Pessary for Pelvic Organ Prolapse COMPLETED NCT06634459 POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment RECRUITING

Other Devices by Panpac Medical Corporation

K161106PANPAC DISPOSABLE VACUUM CURETTES K173351Panpac Flexi Shelf Pessary

Related Devices (Code: HHW)

K173351Panpac Flexi Shelf PessaryPanpac Medical Corporation K190277ProVate Vaginal SupportContipi Medical , Ltd. K183468Revive Reusable Bladder SupportRinovum Subsidiary 2, LLC 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.

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