Cleared Traditional

K180302 - Guardia Access Malleable Obturator

K180302 is the FDA 510(k) clearance for Guardia Access Malleable Obturator by Cook Incorporated. It is a Class 2 Obstetrics & Gynecology device (product code MQF) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K180302 · Cook Incorporated · Obstetrics & Gynecology device
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Oct 2018
Decision
264d
Days
Class 2
Risk

K180302 is an FDA 510(k) clearance for the Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator.... 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 October 24, 2018 after a review of 264 days - an extended review cycle.

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. 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 Cook Incorporated devices

Submission Details

510(k) Number K180302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2018
Decision Date October 24, 2018
Days to Decision 264 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
104d slower than avg
Panel avg: 160d · This submission: 264d
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 23
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K180302.
Kitazato ET Catheters
K192540 · Kitazato Corporation · May 2020
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
K190522 · Allwin Medical Devices, Inc. · Nov 2019
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
K191015 · Cook Incorporated · May 2019
Towako Transmyometrial Embryo Transfer Set
K173431 · William A. Cook Australia Pty. , Ltd. · May 2018
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