Cleared Abbreviated

K051742 - OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH

K051742 is an FDA 510(k) clearance for OOCYTE RETRIEVAL NEEDLE SET, manufactured by Inntec, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Abbreviated 510(k) pathway after a 101-day FDA review.

K051742 · Inntec, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
101d
Days
Class 2
Risk

K051742 is an FDA 510(k) clearance for the OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Inntec, Inc. (Stoughton, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 101 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Inntec, Inc. devices

FDA 510(k) Submission Details - K051742

510(k) Number K051742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2005
Decision Date October 07, 2005
Days to Decision 101 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 160d · This submission: 101d
Pathway characteristics
Standards-based clearance path.

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 24
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K051742.
Follicle Aspiration Set
K161970 · Vitrolife Sweden AB · Jun 2017
KITAZATO OPU NEEDLE
K112462 · Kitazato Medical Co., Ltd. · Nov 2012
FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN
K082727 · Vitrolife Sweden AB · Feb 2009
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · Rocket Medical Plc · Aug 2003
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · CooperSurgical, Inc. · Jan 2003
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
K000205 · Rocket Medical Plc · Apr 2000