Hollister Vertical Drain/Tube Attachment Device

• • Terminated Z-1311-2021 FDA Class II ·initiated 11 Feb 2021

  The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separation might contribute to the potential risk of the tube/drain/catheter migration or loss.

510(k) Number

K932855 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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