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FDA 510(k)

BERNSTEIN(TM) UTERINE MANIPULATOR

K-Number: K932394 · 1995-01-26

ApplicantGm Engineering, Inc.
Decision Date1995-01-26
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BERNSTEIN(TM) UTERINE MANIPULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Gm Engineering, Inc.. It received FDA 510(k) clearance on 1995-01-26 under 510(k) number K932394. 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 BERNSTEIN(TM) UTERINE MANIPULATOR?

BERNSTEIN(TM) UTERINE MANIPULATOR is a medical device that received FDA 510(k) clearance on 1995-01-26. The listed applicant is Gm Engineering, Inc.. The 510(k) number is K932394.

When did BERNSTEIN(TM) UTERINE MANIPULATOR receive FDA 510(k) clearance?

BERNSTEIN(TM) UTERINE MANIPULATOR received FDA 510(k) clearance on 1995-01-26, under 510(k) number K932394.

Who is the listed applicant for BERNSTEIN(TM) UTERINE MANIPULATOR?

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

What is the FDA product code for BERNSTEIN(TM) UTERINE MANIPULATOR?

The FDA product code for BERNSTEIN(TM) UTERINE MANIPULATOR is LKF.

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Other records listing Gm Engineering, 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.

K953348ARTICULATING RETRACTOR TISSUE RETRACTORSK942626CONTINUOUS FLOW BIOPSY PROBEK941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTK942703GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULAK941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTK941660GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT

View all 11 devices →

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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