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)

Margolin HSG Cannula, Goldstein Sonohysterography Catheter

K-Number: K180300 · 2018-10-26

ApplicantCook Incorporated
Decision Date2018-10-26
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Margolin HSG Cannula, Goldstein Sonohysterography Catheter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-10-26 under approval number K180300. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Margolin HSG Cannula, Goldstein Sonohysterography Catheter?

Margolin HSG Cannula, Goldstein Sonohysterography Catheter is a medical device that received FDA 510(k) clearance on 2018-10-26. It is manufactured by Cook Incorporated. The 510(k) number is K180300.

When was Margolin HSG Cannula, Goldstein Sonohysterography Catheter approved by the FDA?

Margolin HSG Cannula, Goldstein Sonohysterography Catheter received FDA 510(k) clearance on 2018-10-26, under approval number K180300.

What company makes Margolin HSG Cannula, Goldstein Sonohysterography Catheter?

Margolin HSG Cannula, Goldstein Sonohysterography Catheter is manufactured by Cook Incorporated.

What is the FDA product code for Margolin HSG Cannula, Goldstein Sonohysterography Catheter?

The FDA product code for Margolin HSG Cannula, Goldstein Sonohysterography Catheter is LKF.

Related Clinical Trials

NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING NCT03472118 High Flow Oxygen in Patients Undergoing Suspension Laryngoscopy Under General Anesthesia TERMINATED

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: LKF)

K160217uVue HSG/SHG CatheterCook Incorporated K163214Unicare System, Unicare ManipulatorClearpath Surgical, Inc. K180291Cook Silicone Balloon HSG CatheterCook Incorporated K172846Uterine ManipulatorBeijing Hangtian Kadi Technology R&D Institute K171604Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum TipCook Incorporated K181770Intrauterine Access Balloon Catheter, Selective Salpingography 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.

↑