Leg Drainage Bag Strap BK6011

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

510(k) Number

K831553 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Thermoelastomer Hot/Cold Compress-7187-

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  FDA 510(k) K823650 Active Cleared 21 Jan 1983

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  FDA 510(k) K801713 Active Cleared 7 Aug 1980

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  FDA 510(k) K823631 Active Cleared 3 Feb 1983

• Bk-2084 Plastic Sock and Stocking Aid

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See all devices from Fred Sammons, Inc. →

• What is the Leg Drainage Bag Strap BK6011 used for?

  The Leg Drainage Bag Strap BK6011 is a Class 2 medical device accessory designed to secure urine collection bags to a patient's leg when using indwelling catheters. It helps keep the drainage bag properly positioned during use in gastroenterology and urology settings.

• Is the Leg Drainage Bag Strap BK6011 reusable or single-use?

  The Leg Drainage Bag Strap BK6011 is supplied as a single-use accessory. It should not be reused between patients as this could compromise patient safety and hygiene. Each strap is intended for one-time use only.

• What are the regulatory specifications for the Leg Drainage Bag Strap BK6011?

  The Leg Drainage Bag Strap BK6011 is regulated under product code KNX with FDA 510(k) clearance K831553. It was received on May 12, 1983, and deemed substantially equivalent on June 16, 1983. It is classified as a Class 2 medical device.

• Is the Leg Drainage Bag Strap BK6011 MRI compatible?

  No, the Leg Drainage Bag Strap BK6011 is not MRI compatible. It should not be used in MRI environments as the materials may not be safe for use in strong magnetic fields, which could pose a risk to patient safety.