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)

COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT

K-Number: K011157 · 2001-05-03

ApplicantCook Urological, Inc.
Decision Date2001-05-03
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2001-05-03 under 510(k) number K011157. 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 COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT?

COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT is a medical device that received FDA 510(k) clearance on 2001-05-03. The listed applicant is Cook Urological, Inc.. The 510(k) number is K011157.

When did COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT receive FDA 510(k) clearance?

COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT received FDA 510(k) clearance on 2001-05-03, under 510(k) number K011157.

Who is the listed applicant for COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT?

The FDA 510(k) record lists Cook Urological, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT?

The FDA product code for COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT 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 Cook Urological, Inc. 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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

View all 104 devices →

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.

↑