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EASYGRIP FLO-41 Precision MIS Delivery System

by Baxter Healthcare Corportation

510(k) K193137

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193137 Date8 Jan 2020ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2051-2021 FDA Class II initiated 15 Jun 2021

    There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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