Cleared Traditional

K983591 - INTRATUBAL TRANSFER SETS

K983591 is the FDA 510(k) clearance for INTRATUBAL TRANSFER SETS by Cook Ob/Gyn. It is a Class 2 Obstetrics & Gynecology device (product code MQF) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K983591 · Cook Ob/Gyn · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
69d
Days
Class 2
Risk

K983591 is an FDA 510(k) clearance for the INTRATUBAL TRANSFER SETS. 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 December 21, 1998 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Ob/Gyn devices

Submission Details

510(k) Number K983591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date December 21, 1998
Days to Decision 69 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
91d faster than avg
Panel avg: 160d · This submission: 69d
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 K983591.
WALLACE CATHETERS-18CM, MODEL 1816
K990350 · CooperSurgical, Inc. · Jul 1999
TRANSMYOMETRIAL EMBRYO TRANSFER SET
K983595 · Cook Ob/Gyn · Feb 1999
GIFT CATHETER SET/S
K983590 · Cook Ob/Gyn · Dec 1998
EMBRYO TRANSFER CATHETERS/SETS
K983594 · Cook Ob/Gyn · Dec 1998
HYSTEROSCOPIC GIFT CATHETER SETS
K983587 · Cook Ob/Gyn · Dec 1998