Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Fertilis microICSI Device

K-Number: K262090 · 2026-10-09

ApplicantFertilis Pty, Ltd.
Decision Date2026-10-09
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Fertilis microICSI Device is the device name listed in this FDA 510(k) record. The listed applicant is Fertilis Pty, Ltd.. It received FDA 510(k) clearance on 2026-10-09 under 510(k) number K262090. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fertilis microICSI Device?

Fertilis microICSI Device is a medical device that received FDA 510(k) clearance on 2026-10-09. The listed applicant is Fertilis Pty, Ltd.. The 510(k) number is K262090.

When did Fertilis microICSI Device receive FDA 510(k) clearance?

Fertilis microICSI Device received FDA 510(k) clearance on 2026-10-09, under 510(k) number K262090.

Who is the listed applicant for Fertilis microICSI Device?

The FDA 510(k) record lists Fertilis Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fertilis microICSI Device?

The FDA product code for Fertilis microICSI Device is MQK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Related Devices (Code: MQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg IncorporationK241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount ApsK241341cryo-GO Vitrification DeviceFujifilm Irvine ScientificK240002G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑