Cleared Traditional

K002850 - MWO-202 3D HYDRAULIC COARSE/FINE MICROM...

K002850 is an FDA 510(k) clearance for MWO-202 3D HYDRAULIC COARSE/FINE MICROM..., manufactured by Narishige Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQJ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K002850 · Narishige Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Oct 2000
Decision
22d
Days
Class 2
Risk

K002850 is an FDA 510(k) clearance for the MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR. Classified as Micromanipulators And Microinjectors, Assisted Reproduction (product code MQJ), Class II - Special Controls.

Submitted by Narishige Co., Ltd. (Setagaya-Ku, Tokyo, JP). The FDA issued a Cleared decision on October 5, 2000 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6150 - 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 Narishige Co., Ltd. devices

FDA 510(k) Submission Details - K002850

510(k) Number K002850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2000
Decision Date October 05, 2000
Days to Decision 22 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
138d faster than avg
Panel avg: 160d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQJ Device Classification - Class 2, Special Controls

Product Code MQJ Micromanipulators And Microinjectors, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6150
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 - MQJ Micromanipulators And Microinjectors, Assisted Reproduction

All 20
Devices cleared under the same product code (MQJ) and FDA review panel - the closest regulatory comparables to K002850.
IM-5B MICROINJECTOR
K003303 · Narishige Co., Ltd. · Nov 2000
IM-6 MICROINJECTOR
K003304 · Narishige Co., Ltd. · Nov 2000
MO-202U THREE-AXIS JOYSTICK HYDRAULIC MICROMANIPULATOR
K003298 · Narishige Co., Ltd. · Nov 2000
MMN-1 COARSE MANIPULATOR
K002653 · Narishige Co., Ltd. · Sep 2000
MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR
K002658 · Narishige Co., Ltd. · Sep 2000
MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR
K002659 · Narishige Co., Ltd. · Sep 2000