Cleared Special

Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters (K172321) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172321 · Cook Incorporated · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
142d
Days
Class 2
Risk

K172321 is an FDA 510(k) clearance for the Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination .... Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 21, 2017 after a review of 142 days - within the typical 510(k) review window.

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

View all Cook Incorporated devices

Submission Details

510(k) Number K172321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2017
Decision Date December 21, 2017
Days to Decision 142 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
18d faster than avg
Panel avg: 160d · This submission: 142d
Pathway characteristics
Modification to existing cleared device.

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 15
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K172321.
Pivet and Soft-Pass Embryo Transfer Catheter Sets
K173103 · Cook Incorporated · Apr 2018
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
K173686 · Cook Incorporated · Apr 2018
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
K172051 · Cook Incorporated · Jan 2018
Soules Intrauterine Insemination Catheter
K163318 · Cook Incorporated · Jul 2017