Prosys Leg Bag

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

510(k) Number

K952208 ↗

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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• What is the primary purpose of the Prosys Leg Bag?

  The Prosys Leg Bag is designed to collect and store urine that is drained from an indwelling catheter system. It serves as a collection reservoir for patients requiring catheterization.

• How is this device regulated?

  The Prosys Leg Bag is classified as a Class 2 medical device under 21 CFR 876.5250. It received FDA 510(k) clearance through the traditional submission process, indicating it is substantially equivalent to legally marketed predicate devices.

• What medical specialty is this device associated with?

  This device is categorized under the Gastroenterology and Urology medical specialties, as it is specifically designed for use with indwelling catheter systems for urine management.