Opticon Direct Male Urinary Catheter for Continuous Drainage

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

510(k) Number

K970716 ↗

FDA Product Code

EZL

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Weingarten Tm Capnographic Intubation Stylette

  Class I

  FDA 510(k) K904999 Active Cleared 26 Jan 1993

• Option-Vm Urinary Catheter/Adpater, Models MV39016, MVA39016

  Class II

  FDA 510(k) K041983 Active Cleared 17 Nov 2004

• Option-VF Urinary Catheter FV14218

  Class II

  FDA 510(k) K023090 Active Cleared 19 Mar 2003

• Hemostasis Valve and Tubing Set

  Class II

  FDA 510(k) K930194 Active Cleared 22 Sep 1993

• Option Epidural Catheters

  Class II

  FDA 510(k) K895476 Active Cleared 19 Jan 1990

• Option-VF Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage Adaptor, Model CDA1000

  Class II

  FDA 510(k) K033830 Active Cleared 9 Jan 2004

See all devices from Opticon Medical, Inc. →

• What clinical settings is this catheter designed for and how is it intended to be used?

  The Opticon Direct Male Urinary Catheter is designed for continuous urinary drainage in male patients within clinical settings like hospitals, nursing homes, or home care environments. It features a balloon mechanism to secure placement inside the bladder, ensuring stable retention while allowing urine to drain through connected tubing. It is intended for single-use only and requires aseptic handling due to its sterile packaging.

• Is this catheter reusable or single-use, and how should it be stored?

  This catheter is explicitly designed for single-use only and must not be reused. It is supplied sterile and packaged for aseptic use, meaning it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the expiration date before use.

• What sizes or models are available for this catheter, and how do I determine the correct fit for a patient?

  The device data lists multiple FEI numbers (e.g., 3000247987, 1018233), which correspond to different sizes or configurations of the Opticon Direct Male Urinary Catheter. While exact measurements (e.g., French sizes) aren’t specified here, these identifiers typically reflect variations in length, balloon volume, or lumen diameter. Clinicians should consult the manufacturer’s product catalog or packaging for precise sizing guidance, as fit depends on patient anatomy and clinical need.

• How is this catheter connected to a drainage system, and are there compatibility requirements?

  The catheter is designed to be connected to standard urinary drainage systems via its tubing outlet. It requires proper aseptic technique during connection to avoid contamination. While the data doesn’t specify exact tubing standards, compatibility is assumed with typical hospital-grade drainage bags and collection systems. Always verify with the manufacturer if using non-standard accessories to ensure proper function and safety.

• What regulatory pathway does this device follow, and how does that affect its use?

  This catheter was cleared under the FDA 510(k) pathway (K970716) as a Class II device under product code EZL, with a decision dated May 16, 1997. This clearance confirms it meets U.S. regulatory standards for retention catheters with balloon functionality, ensuring its safety and effectiveness for continuous urinary drainage in male patients. The clearance does not imply any specific clinical indication beyond what’s described in the device’s labeling.