Cleared Traditional

K130758 - KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER

K130758 is an FDA 510(k) clearance for KRONNER SIDE-KICK UTERINE MANIPULATOR H..., manufactured by Kronner Prototypes, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K130758 · Kronner Prototypes, Inc. · Obstetrics & Gynecology device
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Dec 2013
Decision
266d
Days
Class 2
Risk

K130758 is an FDA 510(k) clearance for the KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Kronner Prototypes, Inc. (Roseburg, US). The FDA issued a Cleared decision on December 11, 2013 after a review of 266 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kronner Prototypes, Inc. devices

FDA 510(k) Submission Details - K130758

510(k) Number K130758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2013
Decision Date December 11, 2013
Days to Decision 266 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 160d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKF Device Classification - Class 2, Special Controls

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - LKF Cannula, Manipulator/injector, Uterine

All 60
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