Cleared Traditional

K001910 - IM-9C MICROINJECTORS

K001910 is an FDA 510(k) clearance for IM-9C MICROINJECTORS, 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 14-day FDA review.

K001910 · Narishige Co., Ltd. · Obstetrics & Gynecology device
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Jul 2000
Decision
14d
Days
Class 2
Risk

K001910 is an FDA 510(k) clearance for the IM-9C MICROINJECTORS. 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 July 7, 2000 after a review of 14 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 - K001910

510(k) Number K001910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2000
Decision Date July 07, 2000
Days to Decision 14 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
146d faster than avg
Panel avg: 160d · This submission: 14d
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 K001910.
MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR
K002659 · Narishige Co., Ltd. · Sep 2000
MOTOR-DRIVE MANIPULATOR MM-89
K002291 · Narishige Co., Ltd. · Sep 2000
3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE
K002293 · Narishige Co., Ltd. · Sep 2000
IM-9A MICROINJECTORS
K001911 · Narishige Co., Ltd. · Jul 2000
IM-9B MICROINJECTORS
K001912 · Narishige Co., Ltd. · Jul 2000
3D MANUAL COARSE MANIPULATOR MN-188NE
K001130 · Narishige Co., Ltd. · Apr 2000