Cleared Traditional

K001130 - 3D MANUAL COARSE MANIPULATOR MN-188NE

K001130 is an FDA 510(k) clearance for 3D MANUAL COARSE MANIPULATOR MN-188NE, 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 11-day FDA review.

K001130 · Narishige Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
11d
Days
Class 2
Risk

K001130 is an FDA 510(k) clearance for the 3D MANUAL COARSE MANIPULATOR MN-188NE. 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 April 21, 2000 after a review of 11 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 - K001130

510(k) Number K001130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date April 21, 2000
Days to Decision 11 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
149d faster than avg
Panel avg: 160d · This submission: 11d
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 K001130.
IM-9C MICROINJECTORS
K001910 · Narishige Co., Ltd. · Jul 2000
IM-9A MICROINJECTORS
K001911 · Narishige Co., Ltd. · Jul 2000
IM-9B MICROINJECTORS
K001912 · Narishige Co., Ltd. · Jul 2000
3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
K001131 · Narishige Co., Ltd. · Apr 2000
GENX MICROTOOLS
K993884 · Intl., Inc. · Feb 2000