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)

EASYGRIP FLO-41 Precision MIS Delivery System

K-Number: K193137 · 2020-01-08

ApplicantBaxter Healthcare Corportation
Decision Date2020-01-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EASYGRIP FLO-41 Precision MIS Delivery System is a medical device manufactured by Baxter Healthcare Corportation. It received FDA 510(k) clearance on 2020-01-08 under approval number K193137. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYGRIP FLO-41 Precision MIS Delivery System?

EASYGRIP FLO-41 Precision MIS Delivery System is a medical device that received FDA 510(k) clearance on 2020-01-08. It is manufactured by Baxter Healthcare Corportation. The 510(k) number is K193137.

When was EASYGRIP FLO-41 Precision MIS Delivery System approved by the FDA?

EASYGRIP FLO-41 Precision MIS Delivery System received FDA 510(k) clearance on 2020-01-08, under approval number K193137.

What company makes EASYGRIP FLO-41 Precision MIS Delivery System?

EASYGRIP FLO-41 Precision MIS Delivery System is manufactured by Baxter Healthcare Corportation.

What is the FDA product code for EASYGRIP FLO-41 Precision MIS Delivery System?

The FDA product code for EASYGRIP FLO-41 Precision MIS Delivery System is GCJ.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026)

Other Devices by Baxter Healthcare Corportation

K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory K233441The Vest APX System (PVAPX1)

Related Devices (Code: GCJ)

K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmCovidien K160801Well Lead Extraction BagWell Lead Medical Co., Ltd. K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp. K161720Standard ClampStandard Bariatrics K162445LiVac Retractor SystemLivac Pty, Ltd. K162584VersaOne Bladeless TrocarCovidien

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.

↑