Cleared Traditional

K991266 - EMBRYO TRANSFER CATHETER CC GLIDER

K991266 is the FDA 510(k) clearance for EMBRYO TRANSFER CATHETER CC GLIDER by Intl., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code MQF) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K991266 · Intl., Inc. · Obstetrics & Gynecology device
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Sep 1999
Decision
149d
Days
Class 2
Risk

K991266 is an FDA 510(k) clearance for the <GENX> EMBRYO TRANSFER CATHETER CC GLIDER. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by <Genx> Intl., Inc. (Madison, US). The FDA issued a Cleared decision on September 9, 1999 after a review of 149 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. 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 Intl., Inc. devices

Submission Details

510(k) Number K991266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1999
Decision Date September 09, 1999
Days to Decision 149 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
11d faster than avg
Panel avg: 160d · This submission: 149d
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 Consultant

Intl., Inc.
MICHAEL D CECCHI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQF Catheter, Assisted Reproduction

All 24
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K991266.
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
WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
K990348 · CooperSurgical, Inc. · Jul 1999
WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
K990349 · CooperSurgical, Inc. · Jul 1999
WALLACE CATHETERS-18CM, MODEL 1816
K990350 · CooperSurgical, Inc. · Jul 1999