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FDA 510(k)

PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5

K-Number: K092980 · 2010-03-11

ApplicantPanpac Medical Corporation
Decision Date2010-03-11
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 is the device name listed in this FDA 510(k) record. The listed applicant is Panpac Medical Corporation. It received FDA 510(k) clearance on 2010-03-11 under 510(k) number K092980. 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 PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5?

PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 is a medical device that received FDA 510(k) clearance on 2010-03-11. The listed applicant is Panpac Medical Corporation. The 510(k) number is K092980.

When did PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 receive FDA 510(k) clearance?

PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 received FDA 510(k) clearance on 2010-03-11, under 510(k) number K092980.

Who is the listed applicant for PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5?

The FDA 510(k) record lists Panpac Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5?

The FDA product code for PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 is LKF.

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Other records listing Panpac Medical Corporation 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.

K173351Panpac Flexi Shelf PessaryK161106PANPAC DISPOSABLE VACUUM CURETTESK153422Panpac Disposable Pessary Fitting SetK130273PANPAC VAGINAL DILATORSK102898BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONEK092982THE PANPAC SUCTION CURETTE

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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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