Cleared Traditional

K013497 - FAS SET #4551

K013497 is an FDA 510(k) clearance for FAS SET #4551, manufactured by Gynetics Medical Products NV. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K013497 · Gynetics Medical Products NV · Obstetrics & Gynecology device
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Nov 2001
Decision
18d
Days
Class 2
Risk

K013497 is an FDA 510(k) clearance for the FAS SET #4551. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Gynetics Medical Products NV (Irvine, US). The FDA issued a Cleared decision on November 9, 2001 after a review of 18 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K013497

510(k) Number K013497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date November 09, 2001
Days to Decision 18 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d faster than avg
Panel avg: 161d · This submission: 18d
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 32
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K013497.
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · Rocket Medical Plc · Aug 2003
WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS
K031622 · Portex , Ltd. · Jun 2003
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · CooperSurgical, Inc. · Jan 2003
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
K012068 · Sims Portex , Ltd. · Aug 2001
OVARIAL BIOPSY SET 324102-324108
K003056 · Labotect Labor-Technik Gottingen · Dec 2000
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
K000205 · Rocket Medical Plc · Apr 2000
K013497 · FAS SET #4551
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