Cleared Traditional

K983593 - OVUM PICK-UP ASPIRATION NEEDLES

K983593 is an FDA 510(k) clearance for OVUM PICK-UP ASPIRATION NEEDLES, manufactured by Cook Ob/Gyn. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K983593 · Cook Ob/Gyn · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
100d
Days
Class 2
Risk

K983593 is an FDA 510(k) clearance for the OVUM PICK-UP ASPIRATION NEEDLES. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on January 21, 1999 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6100 - 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

FDA 510(k) Submission Details - K983593

510(k) Number K983593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date January 21, 1999
Days to Decision 100 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
60d faster than avg
Panel avg: 160d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQE Device Classification - Class 2, Special Controls

Product Code MQE Needle, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6100
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 - MQE Needle, Assisted Reproduction

All 26
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K983593.
SINGLE LUMEN SIDEPORT NEEDLE
K991264 · Intl., Inc. · Sep 1999
SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
K991273 · Swemed Lab International AB · Aug 1999
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU
K990913 · Laboratoires Prodimed · Jun 1999