Cleared Traditional

MN-4 COARSE MANIPULATOR (K010298) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010298 · Narishige Co., Ltd. · Obstetrics & Gynecology device
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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

Submission Details

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
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.

Device Classification

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.