Cleared Special

K123258 - THE ADVANCE CATHETER FOR HSG AND SIS

K123258 is an FDA 510(k) clearance for THE ADVANCE CATHETER FOR HSG AND SIS, manufactured by Catheter Research, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Special 510(k) pathway after a 105-day FDA review.

K123258 · Catheter Research, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
105d
Days
Class 2
Risk

K123258 is an FDA 510(k) clearance for the THE ADVANCE CATHETER FOR HSG AND SIS. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Catheter Research, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 31, 2013 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K123258

510(k) Number K123258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2012
Decision Date January 31, 2013
Days to Decision 105 days
Submission Type Special
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
56d faster than avg
Panel avg: 161d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

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 86
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