510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010298Substantially Equivalent

Mn-4 Coarse Manipulator

Narishige Co., Ltd., Setagaya-Ku, Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010298 is the FDA 510(k) clearance record for MN-4 COARSE MANIPULATOR, a class II device, cleared for Narishige Co., Ltd. on under FDA product code MQJ (Micromanipulators And Microinjectors, Assisted Reproduction). FDA records list 20 510(k) clearances for Narishige Co., Ltd., from to . As of , FDA records show no recalls naming K010298.

Clearance record

Decision date
Received
(44 days to decision)
Product code
MQJ Micromanipulators And Microinjectors, Assisted Reproduction
Regulation
21 CFR 884.6150
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Narishige Co., Ltd. 27-9 Minamikarasuyama 4-Chome, Setagaya-Ku, Tokyo, JP
510(k) summary
Summary
Third party review
No

Clearances, product code MQJ

Trailing 12 months

FDA records hold no clearances under product code MQJ in the trailing twelve months.

FDA records show no clearances under product code MQJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260