Argyle Rigid Urine Measuring/Coll. Device

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

Full name

Argyle Rigid Urine Measuring/Coll. Dev.

510(k) Number

K801522 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Argyle Vac-U-Care 100cc Suct. Reservoir

  Class I

  FDA 510(k) K801372 Active Cleared 26 Jun 1980

• Argyle Aspr-Care Closed Suction System

  Class I

  FDA 510(k) K934723 Active Cleared 30 Nov 1993

• Labcer Fibrinogen Assay Kit & Calibr.

  Class II

  FDA 510(k) K812570 Active Cleared 2 Oct 1981

• Monoject(R) Trace Element Blood Collection Tube

  Class II

  FDA 510(k) K883320 Active Cleared 27 Sep 1988

• Monoject Samplette Amber Capillary Serum Separator

  Class I

  FDA 510(k) K875061 Active Cleared 12 Jan 1988

• Argyle Turkel Safety Trocar Thoracic Catheter

  Class I

  FDA 510(k) K933510 Active Cleared 24 Feb 1994

See all devices from Sherwood Medical Co. →

• Is this device reusable or intended for single-use only, and how does that affect its clinical use?

  The Argyle Rigid Urine Measuring/Coll. Device is explicitly designed for single-use in clinical settings like hospitals and urology/gastroenterology departments. This ensures patient safety by eliminating cross-contamination risks, as it is supplied sterile and not intended for reuse. Single-use also simplifies inventory management and reduces the need for reprocessing or sterilization protocols.

• What storage conditions are required for this device, and how should it be handled before use?

  The device requires no special storage conditions beyond standard medical device protocols. It is supplied sterile, so it should be stored in a clean, dry environment protected from physical damage or contamination. Once opened or exposed, it must be used immediately to maintain sterility, as single-use devices are not intended for later reprocessing.

• What makes this device different from other urine collection systems, particularly in terms of its rigid construction?

  The Argyle Rigid Urine Measuring/Coll. Device features a rigid construction, which distinguishes it from flexible alternatives by providing a more secure attachment to catheter tubing. This design helps prevent accidental dislodgment or leakage while enabling accurate urine volume measurement—critical for clinical monitoring of patients with indwelling catheters. The rigidity also ensures stability during use.

• How is this device regulated, and what does its FDA clearance status imply for buyers?

  This device holds FDA 510(k) clearance (K801522) under product code KNX, classified as a Class II device under regulation 876.5250. The clearance was granted as Substantially Equivalent (SESE) to a predicate device, meaning it meets FDA standards for safety and effectiveness. Buyers can rely on this status to confirm the device’s compliance with U.S. regulatory requirements for urine collection systems, though they should always verify current compliance with the manufacturer.