Cleared Traditional

K983595 - TRANSMYOMETRIAL EMBRYO TRANSFER SET

K983595 is the FDA 510(k) clearance for TRANSMYOMETRIAL EMBRYO TRANSFER SET by Cook Ob/Gyn. It is a Class 2 Obstetrics & Gynecology device (product code MQF) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K983595 · Cook Ob/Gyn · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
118d
Days
Class 2
Risk

K983595 is an FDA 510(k) clearance for the TRANSMYOMETRIAL EMBRYO TRANSFER SET. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on February 8, 1999 after a review of 118 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 Cook Ob/Gyn devices

Submission Details

510(k) Number K983595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date February 08, 1999
Days to Decision 118 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
42d faster than avg
Panel avg: 160d · This submission: 118d
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 K983595.
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
GIFT CATHETER SET/S
K983590 · Cook Ob/Gyn · Dec 1998
INTRATUBAL TRANSFER SETS
K983591 · Cook Ob/Gyn · Dec 1998
EMBRYO TRANSFER CATHETERS/SETS
K983594 · Cook Ob/Gyn · Dec 1998