Cleared Traditional

K082727 - FOLLICLE ASPIRATION SET

K082727 is the FDA 510(k) clearance for FOLLICLE ASPIRATION SET by Vitrolife Sweden AB. It is a Class 2 Obstetrics & Gynecology device (product code MQE) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K082727 · Vitrolife Sweden AB · Obstetrics & Gynecology device
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Feb 2009
Decision
142d
Days
Class 2
Risk

K082727 is an FDA 510(k) clearance for the FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Vitrolife Sweden AB (Kungsbacka, SE). The FDA issued a Cleared decision on February 6, 2009 after a review of 142 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 Vitrolife Sweden AB devices

Submission Details

510(k) Number K082727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2008
Decision Date February 06, 2009
Days to Decision 142 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
18d faster than avg
Panel avg: 160d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K082727.
Single Lumen Ovum Aspiration Needles
K171625 · Willian A. Cook Australia Pty, Ltd. · Jan 2018
Follicle Aspiration Set, Reduced Single Lumen
K172050 · Vitrolife Sweden AB · Nov 2017
Follicle Aspiration Set
K161970 · Vitrolife Sweden AB · Jun 2017
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · CooperSurgical, Inc. · Jan 2003
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K994417 · Cook Urological, Inc. · Mar 2000
OVUM PICK-UP ASPIRATION NEEDLES
K983593 · Cook Ob/Gyn · Jan 1999