Cleared Traditional

K143669 - MedGyn Straight IUI Catheter

K143669 is the FDA 510(k) clearance for MedGyn Straight IUI Catheter by Medgyn Products, Inc.. It is a Class 2 Obstetrics & Gynecology device (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)
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.

View all Medgyn Products, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
174d slower than avg
Panel avg: 160d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K143669.
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
K172051 · Cook Incorporated · Jan 2018
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
K172321 · Cook Incorporated · Dec 2017
Soules Intrauterine Insemination Catheter
K163318 · Cook Incorporated · Jul 2017