Cleared Traditional

K010298 - MN-4 COARSE MANIPULATOR

K010298 is an FDA 510(k) clearance for MN-4 COARSE MANIPULATOR, 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 44-day FDA review.

K010298 · Narishige Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
44d
Days
Class 2
Risk

K010298 is an FDA 510(k) clearance for the MN-4 COARSE MANIPULATOR. 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 March 16, 2001 after a review of 44 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 - K010298

510(k) Number K010298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2001
Decision Date March 16, 2001
Days to Decision 44 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
116d faster than avg
Panel avg: 160d · This submission: 44d
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 K010298.
MICROMANIPULATOR SET
K120877 · Narishige Co., Ltd. · Jun 2012
IM-11 PNEUMATIC MICROINJECTOR
K113712 · Narishige Co., Ltd. · Mar 2012
MM-87 MOTOR-DRIVE MANIPULATOR
K011420 · Narishige Co., Ltd. · Jun 2001
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
K003300 · Narishige Co., Ltd. · Nov 2000
IM-5A INJECTOR
K003302 · Narishige Co., Ltd. · Nov 2000
IM-5B MICROINJECTOR
K003303 · Narishige Co., Ltd. · Nov 2000