Cleared Traditional

K143669 - MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter

K143669 is an FDA 510(k) clearance for MedGyn Straight IUI Catheter, manufactured by Medgyn Products, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K143669 · Medgyn Products, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
334d
Days
Class 2
Risk

K143669 is an FDA 510(k) clearance for the MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini I.... Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Medgyn Products, Inc. (Addison, US). The FDA issued a Cleared decision on November 23, 2015 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - 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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K143669

510(k) Number K143669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2014
Decision Date November 23, 2015
Days to Decision 334 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
173d slower than avg
Panel avg: 161d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQF Device Classification - Class 2, Special Controls

Product Code MQF Catheter, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6110
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 - MQF Catheter, Assisted Reproduction

All 52
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K143669.
Kitazato IUI Catheter
K162667 · Kitazato Corporation · May 2017
Transem and EchoGen Embryo Transfer Catheters
K161547 · Origio A/S · Mar 2017
CrossBay IVF Embryo Transfer Catheter Set
K162064 · Crossbay Medical, Inc. · Jan 2017
FERTILIGENT SLOW RELEASE IUI CATHETER KIT
K141666 · Fertiligent, Ltd. · Feb 2015
KITAZATO IUI CATHETER
K131491 · Kitazato Medical Co., Ltd. · Sep 2013
IUI CATHETERS
K112396 · Kitazato Medical Co., Ltd. · Nov 2012
K143669 · MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
Download PDF FDA Summary Medgyn Products, Inc.