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)

OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE

K-Number: K053494 · 2006-03-23

ApplicantFertipro NV
Decision Date2006-03-23
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE is the device name listed in this FDA 510(k) record. The listed applicant is Fertipro NV. It received FDA 510(k) clearance on 2006-03-23 under 510(k) number K053494. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE?

OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE is a medical device that received FDA 510(k) clearance on 2006-03-23. The listed applicant is Fertipro NV. The 510(k) number is K053494.

When did OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE receive FDA 510(k) clearance?

OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE received FDA 510(k) clearance on 2006-03-23, under 510(k) number K053494.

Who is the listed applicant for OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE?

The FDA 510(k) record lists Fertipro NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE?

The FDA product code for OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE is MQL.

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_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Fertipro NV as applicant

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.

K242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinK221547InActiv BlueK070135VITRIFREEZE MEDIUM; VITRITHAW MEDIUM

Related Devices (Code: MQL)

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.

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

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.

↑