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FDA 510(k)

INTRAUTERINE INSEMINATION CATHETER

K-Number: K870551 · 1987-03-02

ApplicantCook Ob/Gyn
Decision Date1987-03-02
Product CodeHDR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTRAUTERINE INSEMINATION CATHETER 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 1987-03-02 under 510(k) number K870551. The device is classified under product code HDR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAUTERINE INSEMINATION CATHETER?

INTRAUTERINE INSEMINATION CATHETER is a medical device that received FDA 510(k) clearance on 1987-03-02. The listed applicant is Cook Ob/Gyn. The 510(k) number is K870551.

When did INTRAUTERINE INSEMINATION CATHETER receive FDA 510(k) clearance?

INTRAUTERINE INSEMINATION CATHETER received FDA 510(k) clearance on 1987-03-02, under 510(k) number K870551.

Who is the listed applicant for INTRAUTERINE INSEMINATION CATHETER?

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 INTRAUTERINE INSEMINATION CATHETER?

The FDA product code for INTRAUTERINE INSEMINATION CATHETER is HDR.

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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: HDR)

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.

K242031Béa Applicator (BAP-GB-01)Stepone Fertility Ltd (T/A Béa Fertility)K222969FERTI-LILY Conception CupRosesta Medical BVK993953OVES CERVICAL CAPVeos , Ltd.K945131IMAGYN INTRAUTERINE INSEMINATION DEVICEImagyn Medical, Inc.K950714COOK INSEMINATION CUPCook Urological, Inc.K902171MINISPACE(TM) IUI CATHETERPharmacia, 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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