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FDA 510(k)

PELVX DONUT, PELVX CUBE

K-Number: K974117 · 1998-04-27

ApplicantDeschutes Medical Products, Inc.
Decision Date1998-04-27
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PELVX DONUT, PELVX CUBE is the device name listed in this FDA 510(k) record. The listed applicant is Deschutes Medical Products, Inc.. It received FDA 510(k) clearance on 1998-04-27 under 510(k) number K974117. 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 PELVX DONUT, PELVX CUBE?

PELVX DONUT, PELVX CUBE is a medical device that received FDA 510(k) clearance on 1998-04-27. The listed applicant is Deschutes Medical Products, Inc.. The 510(k) number is K974117.

When did PELVX DONUT, PELVX CUBE receive FDA 510(k) clearance?

PELVX DONUT, PELVX CUBE received FDA 510(k) clearance on 1998-04-27, under 510(k) number K974117.

Who is the listed applicant for PELVX DONUT, PELVX CUBE?

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

What is the FDA product code for PELVX DONUT, PELVX CUBE?

The FDA product code for PELVX DONUT, PELVX CUBE is HHW.

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Other records listing Deschutes Medical Products, Inc. as applicant

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.

K002329PELVX GELLHORN VAGINAL PESSARY 603-608K994079REFLEX TREATMENT SYSTEMK990593PELVX INCONTINENCE DISH, MODEL 301-306K974116PELVX INCONTINENCE RINGK974115PELVX RING, PELVX RING WITH SUPPORTK934552PERIPUMP

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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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