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FDA 510(k)

KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER

K-Number: K130758 · 2013-12-11

ApplicantKronner Prototypes, Inc.
Decision Date2013-12-11
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Kronner Prototypes, Inc.. It received FDA 510(k) clearance on 2013-12-11 under 510(k) number K130758. 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 KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER?

KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER is a medical device that received FDA 510(k) clearance on 2013-12-11. The listed applicant is Kronner Prototypes, Inc.. The 510(k) number is K130758.

When did KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER receive FDA 510(k) clearance?

KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER received FDA 510(k) clearance on 2013-12-11, under 510(k) number K130758.

Who is the listed applicant for KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER?

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

What is the FDA product code for KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER?

The FDA product code for KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER is LKF.

Related Clinical Trials

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.

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Other records listing Kronner Prototypes, 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.

K000663KRONNER LOW PROFILE SCOPE HOLDERK973543KRONNER LOW PROFILE SCOPE HOLDERK941348KRONNER LAPAROSCOPIC HOLDER

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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