Hollister Retracted Penis Pouch

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K970443 ↗

FDA Product Code

EXI

Device Class

Class I

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• Heelbo Quilted Torso Restraint

  Class I

  FDA 510(k) K963108 Active Cleared 9 Oct 1996

• Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe

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  Class II

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