FDA 510(k)

IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500

K-Number: K991348 · 2000-05-17

Decision Date2000-05-17

Product CodeMQL

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2000-05-17 under 510(k) number K991348. 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 IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500?

IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 is a medical device that received FDA 510(k) clearance on 2000-05-17. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K991348.

When did IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 receive FDA 510(k) clearance?

IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 received FDA 510(k) clearance on 2000-05-17, under 510(k) number K991348.

Who is the listed applicant for IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500?

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

What is the FDA product code for IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500?

The FDA product code for IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vitrolife Sweden AB as applicant

K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)K241662Ultrasound Transducer Cover K240605Ultra RapidWarm™ Blast K202862Gx-IVF, Gx-TL, Gx-MOPS PLUS K183486RapidVit™ Oocyte, RapidWarm™ Oocyte K181461Rapid-i™ Kit

View all 36 devices →

Related Devices (Code: MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin 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.