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FDA 510(k)

FEMALE CONTINENCE DEVICE

K-Number: K883721 · 1988-10-03

ApplicantCook Ob/Gyn
Decision Date1988-10-03
Product CodeHHW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMALE CONTINENCE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 1988-10-03 under 510(k) number K883721. 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 FEMALE CONTINENCE DEVICE?

FEMALE CONTINENCE DEVICE is a medical device that received FDA 510(k) clearance on 1988-10-03. The listed applicant is Cook Ob/Gyn. The 510(k) number is K883721.

When did FEMALE CONTINENCE DEVICE receive FDA 510(k) clearance?

FEMALE CONTINENCE DEVICE received FDA 510(k) clearance on 1988-10-03, under 510(k) number K883721.

Who is the listed applicant for FEMALE CONTINENCE DEVICE?

The FDA 510(k) record lists Cook Ob/Gyn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMALE CONTINENCE DEVICE?

The FDA product code for FEMALE CONTINENCE DEVICE is HHW.

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Other records listing Cook Ob/Gyn 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.

K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500K030441SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KITK023850SYDNEY IVF EMBRYO BIOPSY MEDIUMK013597TAMPONADE UTERINE BALLOON CATHETER SETK002385COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,K002383COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT

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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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