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Hollister Female Urinary Collect Sys

by Hollister, Inc. 510(k)

Active United States

510(k) K820234

Overview

A collector, urine, (and accessories) for indwelling catheter is a device intended to collect urine from an indwelling urinary catheter. This device is designed for external urinary collection in female patients.

It is supplied as a non-sterile, single-use device for use in healthcare settings. The device connects to leg bag or gravity drainage systems via a universal connector compatible with most leg or night drainage bags. It is not made with natural rubber latex. Authorization is based on FDA 510(k) clearance K820234, classified as a Class II device under regulation number 876.5250 with product code KNX.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820234 Date10 Feb 1982ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KNX
Device Class
Class II
Regulation
21 CFR Part 876.5250
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Hollister Female Urinary Collect Sys used for?

    It is intended to collect urine from an indwelling urinary catheter in female patients, designed for external urinary collection in healthcare settings.

  • Is the Hollister Female Urinary Collect Sys sterile or non-sterile, and is it reusable?

    The device is supplied as a non-sterile, single-use device, meaning it is not sterilized before use and is intended for one-time use only to reduce infection risk.

  • How does the Hollister Female Urinary Collect Sys connect to drainage systems?

    It connects to leg bag or gravity drainage systems through a universal connector that is compatible with most standard leg or night drainage bags.

  • Does the Hollister Female Urinary Collect Sys contain natural rubber latex?

    No, the device is not made with natural rubber latex, making it suitable for patients or staff with latex sensitivities or allergies.