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Multiple Bag, Leg

by Luth Corp.

510(k) K840283

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK840283 Date13 Apr 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
KNX
Device Class
Class II
Regulation
21 CFR Part 876.5250
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Collector, Urine, (And Accessories) For Indwelling Catheter, designed to collect and contain urine drained from an indwelling urinary catheter. It is a sterile, single-use bag configured for attachment to the leg, providing a portable and discreet collection solution for patients requiring continuous urinary drainage.

The Multiple Bag, Leg is intended for use in clinical settings such as hospitals, nursing homes, and home healthcare environments. Supplied sterile and intended for single-use only, it is classified as a Class II medical device under FDA regulations (876.5250). The device is not MRI-compatible and must be stored in a clean, dry environment prior to use, adhering to standard sterile packaging guidelines. FDA clearance (510(k) K840283) was granted in 1984 under the Traditional pathway.

Other devices from Luth Corp.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical environments is this leg-mounted urine collection bag designed for use in?

    The Multiple Bag, Leg is specifically designed for use in clinical settings such as hospitals, nursing homes, and home healthcare environments. Its portable and discreet leg attachment makes it suitable for patients requiring continuous urinary drainage in these settings.

  • Is this device reusable or intended for single-use only, and how should it be stored?

    This device is intended for single-use only and comes sterile. It must be stored in a clean, dry environment prior to use, adhering to standard sterile packaging guidelines to maintain its integrity.

  • What regulatory pathway was used for FDA clearance, and when was it granted?

    The Multiple Bag, Leg received FDA clearance under the Traditional 510(k) pathway with clearance number K840283. The decision was made on April 13, 1984, and it was determined to be substantially equivalent to a predicate device.

  • Can this device be used in an MRI environment, or does it have any MRI-related restrictions?

    The Multiple Bag, Leg is not MRI-compatible, meaning it should not be used in an MRI environment. This restriction is explicitly noted in the device’s specifications.

  • What types of medical specialties or advisory committees were involved in the review of this device?

    The device was reviewed by the Gastroenterology and Urology advisory committees (referred to as the GU committee) during its regulatory submission process. These committees provide expert input on medical devices related to urinary and gastrointestinal systems.