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FDA 510(k)

MAJOLI UTERINE MANIPULATOR/INJECTOR

K-Number: K911887 · 1991-07-26

ApplicantCook Ob/Gyn
Decision Date1991-07-26
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MAJOLI UTERINE MANIPULATOR/INJECTOR 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 1991-07-26 under 510(k) number K911887. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAJOLI UTERINE MANIPULATOR/INJECTOR?

MAJOLI UTERINE MANIPULATOR/INJECTOR is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is Cook Ob/Gyn. The 510(k) number is K911887.

When did MAJOLI UTERINE MANIPULATOR/INJECTOR receive FDA 510(k) clearance?

MAJOLI UTERINE MANIPULATOR/INJECTOR received FDA 510(k) clearance on 1991-07-26, under 510(k) number K911887.

Who is the listed applicant for MAJOLI UTERINE MANIPULATOR/INJECTOR?

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 MAJOLI UTERINE MANIPULATOR/INJECTOR?

The FDA product code for MAJOLI UTERINE MANIPULATOR/INJECTOR is LKF.

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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: LKF)

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.

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, 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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