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MMG Disposable Urinary Leg Bag

by Medical Marketing Group

510(k) K800694

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 NumberK800694 Date30 May 1980ClearedStatusActive

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  • Withdrawn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, 28 Sep 2026

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

A collector, urine, (and accessories) for indwelling catheter is a device intended to collect urine from an indwelling urinary catheter. This device is a disposable urinary leg bag designed for use with indwelling catheters to facilitate urine drainage and collection.

The device is supplied as a single-use, non-sterile product intended for use in clinical or home care settings. It is regulated as a Class II medical device under FDA 510(k) clearance K800694, with product code KNX and regulation number 876.5250, and was determined to be substantially equivalent to a predicate device on May 30, 1980.

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Questions

AI-generated answers, 28 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 is the MMG Disposable Urinary Leg Bag used for?

    It is intended to collect urine from an indwelling urinary catheter, facilitating drainage and collection in both clinical and home care environments as a urine collector device.

  • Is the MMG Disposable Urinary Leg Bag sterile or non-sterile when supplied?

    The device is supplied as a non-sterile product, meaning it does not require sterilization prior to use and is intended for single-use applications in accordance with its labeling.

  • Can the MMG Disposable Urinary Leg Bag be reused after initial use?

    No, it is designated as a single-use device and should not be reused; reusing it may compromise safety and performance, as it is designed for one-time disposal after use.

  • What regulatory pathway was used for the MMG Disposable Urinary Leg Bag?

    The device received FDA 510(k) clearance under submission K800694, demonstrating substantial equivalence to a predicate device, and is classified as a Class II medical device under product code KNX.