510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K090429Substantially Equivalent

Nunc Ivf Centerwell and Icsi Dishes

Thermo Fisher Scientific (Nalge Nunc Intl), Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090429 is the FDA 510(k) clearance record for NUNC IVF CENTERWELL AND ICSI DISHES, a class II device, cleared for Thermo Fisher Scientific (Nalge Nunc Intl) on under FDA product code MQK (Labware, Assisted Reproduction). FDA records list one 510(k) clearance for Thermo Fisher Scientific (Nalge Nunc Intl). As of , FDA records show no recalls naming K090429.

Clearance record

Decision date
Received
(211 days to decision)
Product code
MQK Labware, Assisted Reproduction
Regulation
21 CFR 884.6160
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Thermo Fisher Scientific (Nalge Nunc Intl) 75 Panorama Creek Dr., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQK

Trailing 12 months

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

FDA records show no clearances under product code MQK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MQK, 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