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

FDA 510(k)

Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters

K-Number: K172321 · 2017-12-21

ApplicantCook Incorporated
Decision Date2017-12-21
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2017-12-21 under approval number K172321. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters?

Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters is a medical device that received FDA 510(k) clearance on 2017-12-21. It is manufactured by Cook Incorporated. The 510(k) number is K172321.

When was Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters approved by the FDA?

Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters received FDA 510(k) clearance on 2017-12-21, under approval number K172321.

What company makes Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters?

Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters is manufactured by Cook Incorporated.

What is the FDA product code for Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters?

The FDA product code for Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters is MQF.

Other Devices by Cook Incorporated

K160884CXI Support Catheter K161822Torcon NB Advantage Catheters K161496Turbo-Flo PICC Sets K160217uVue HSG/SHG Catheter K161002Aprima Smartesis Centesis Pump K153761Emergency Transtracheal Airway Catheter

View all 147 devices →

Related Devices (Code: MQF)

K163318Soules Intrauterine Insemination CatheterCook Incorporated K162878Kitazato ET CathetersKitazato Corporation K162667Kitazato IUI CatheterKitazato Corporation K161547Transem and EchoGen Embryo Transfer CathetersOrigio A/S K162064CrossBay IVF Embryo Transfer Catheter SetCrossbay Medical, Inc. K180302Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing CatheterCook Incorporated

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.

↑