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FDA 510(k)

UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450

K-Number: K010296 · 2001-04-11

ApplicantMarina Medical Instruments, Inc.
Decision Date2001-04-11
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 is the device name listed in this FDA 510(k) record. The listed applicant is Marina Medical Instruments, Inc.. It received FDA 510(k) clearance on 2001-04-11 under 510(k) number K010296. 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 UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450?

UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 is a medical device that received FDA 510(k) clearance on 2001-04-11. The listed applicant is Marina Medical Instruments, Inc.. The 510(k) number is K010296.

When did UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 receive FDA 510(k) clearance?

UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 received FDA 510(k) clearance on 2001-04-11, under 510(k) number K010296.

Who is the listed applicant for UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450?

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

What is the FDA product code for UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450?

The FDA product code for UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 is LKF.

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Other records listing Marina Medical Instruments, 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.

K042534MARINA MEDICAL FINGER PROTECTORSK031463MARINA MEDICAL SILICONE PESSARYK021876MAS WITH OR WITHOUT SYRINGEK023725HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247

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

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