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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 the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corportation. It received FDA 510(k) clearance on 2020-01-08 under 510(k) 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. The listed applicant is Baxter Healthcare Corportation. The 510(k) number is K193137.

When did EASYGRIP FLO-41 Precision MIS Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for EASYGRIP FLO-41 Precision MIS Delivery System?

The FDA 510(k) record lists Baxter Healthcare Corportation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Baxter Healthcare Corportation 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.

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Related Devices (Code: GCJ)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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