Kronner Side-Kick Uterine Manipulator Holder

FDA 510(k) K130758 · Kronner Prototypes, Inc.

Substantially Equivalent

510(k) numberK130758

Submission

Device name
Kronner Side-Kick Uterine Manipulator Holder
Applicant
Kronner Prototypes, Inc.
Roseburg, OR, US
Received
March 20, 2013
Decision date
December 11, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LKF – Cannula, Manipulator/Injector, Uterine
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

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K242002FemVue MINI Saline-Air DeviceLKF · Traditional Femasys, Inc.11/22/2024SE
K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)LKF · Traditional Li Medical Corporation , Ltd.10/16/2024SE
K241693FemChec Controlled Saline-Air Device (FCD-250)LKF · Traditional Femasys, Inc.09/06/2024SE
K222798Rejoni Intrauterine CatheterLKF · Traditional Rejoni, Inc.12/16/2022SE
K223064ALLY II Uterine Positioning System™ (UPS)LKF · Special CooperSurgical, Inc.10/28/2022SE
K220202Uterine ElevatOR PRO with OccludOR BalloonLKF · Traditional The O R Company Pty, Ltd.03/31/2022SE
K212505DUMI ManipulatORLKF · Traditional The O R Company Pty, Ltd.01/10/2022SE
K181770Intrauterine Access Balloon Catheter, Selective Salpingography CatheterLKF · Traditional Cook Incorporated03/29/2019SE

More from Cook Incorporated

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K000663Kronner Low Profile Scope HolderGCJ · Traditional 05/02/2000SE
K973543Kronner Low Profile Scope HolderGCJ · Traditional 01/12/1998SE
K941348Kronner Laparoscopic HolderGCJ · Traditional 11/14/1994SE

Questions and answers

When was Kronner Side-Kick Uterine Manipulator Holder cleared by the FDA?

Kronner Side-Kick Uterine Manipulator Holder (K130758) received a 510(k) decision of Substantially Equivalent on December 11, 2013, 266 days after the submission was received.

What is the product code of K130758?

The FDA product code is LKF – Cannula, Manipulator/Injector, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.