Cleared Traditional

IM-9B MICROINJECTORS (K001912) - FDA 510(k) Clearance

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

K001912 · Narishige Co., Ltd. · Obstetrics & Gynecology device
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Jul 2000
Decision
14d
Days
Class 2
Risk

K001912 is an FDA 510(k) clearance for the IM-9B 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

Submission Details

510(k) Number K001912 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
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.

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.