O'Neil Urinary Catheter Introducer

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

510(k) Number

K884819 ↗

FDA Product Code

KNY

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• The Mmg 5 in 1 Connector

  Class I

  FDA 510(k) K863912 Active Cleared 27 Oct 1986

• Mmg Urinary Drainage Tubing

  Class II

  FDA 510(k) K811469 Active Cleared 12 Jun 1981

• Mmg Uro-Self Catheter

  Class II

  FDA 510(k) K871999 Active Cleared 25 Aug 1987

• MMG Disposable Urinary Leg Bag

  Class II

  FDA 510(k) K800694 Active Cleared 30 May 1980

• Disposable Urinary Legbag W/Strap

  Class II

  FDA 510(k) K821168 Active Cleared 24 May 1982

• Mmg/O'neil Urinary Catheterization System Kit

  Class II

  FDA 510(k) K910022 Active Cleared 2 Apr 1991

See all devices from Medical Marketing Group →

• What is the primary purpose of the O'Neil Urinary Catheter Introducer and how does it benefit patients during catheterization?

  The O'Neil Urinary Catheter Introducer is designed to assist in the insertion of urinary catheters by serving as a guide or introducer. Its purpose is to ease the passage of catheters through the urethra, which helps reduce trauma to the urethral tissue and improves the success rate of the catheterization procedure. This can lead to a more comfortable experience for patients and potentially fewer complications during the process.

• Is the O'Neil Urinary Catheter Introducer intended for single-use or reusable applications, and what does this mean for clinical workflow?

  The O'Neil Urinary Catheter Introducer is explicitly supplied as a single-use device. This means each unit is intended for one-time use only and should not be reused across patients. Clinically, this ensures infection control and reduces the risk of cross-contamination, which is critical in sterile procedures like urinary catheterization. Single-use also simplifies inventory management and disposal protocols.

• What are the key storage considerations for the O'Neil Urinary Catheter Introducer, given its non-sterile classification?

  Since the O'Neil Urinary Catheter Introducer is non-sterile, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. While not sterile, maintaining a sterile field during use (e.g., with sterile gloves and drapes) is essential for infection control. Always follow manufacturer guidelines for packaging integrity and expiration dates to ensure optimal performance.

• How is the regulatory pathway for this device structured, and what does the FDA 510(k) clearance indicate about its safety and effectiveness?

  The O'Neil Urinary Catheter Introducer follows the FDA 510(k) clearance pathway, which demonstrates that it is *substantially equivalent* to a legally marketed device already on the market. This clearance (K884819) indicates that the FDA has reviewed its design, manufacturing processes, and clinical rationale and determined it meets regulatory standards for safety and performance. The device is classified as Class II, meaning it has special controls to ensure its effectiveness but does not pose the highest risk (like Class III devices).

• In what clinical settings is this device most commonly used, and what types of healthcare professionals typically utilize it?

  The O'Neil Urinary Catheter Introducer is primarily used in urological and gastroenterological settings, where urinary catheterization is performed. It is most commonly utilized by urologists, nurses, and other trained healthcare professionals who perform catheterization procedures. Its design is particularly helpful in scenarios where catheter insertion may be challenging, such as in patients with strictures or anatomical variations, to minimize trauma and improve procedural success.