No Profile Olbert Catheter System for Urology

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

510(k) Number

K905181 ↗

FDA Product Code

EZN

Device Class

Class II

Regulation

21 CFR Part 876.5470

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Meadox(R) Surgimed Olbert Cath Syst for Urology

  Class II

  FDA 510(k) K904983 Active Cleared 30 Jan 1991

• Lunderquist - Ring Ptc Drainage Catheter

  Class II

  FDA 510(k) K861220 Active Cleared 19 May 1986

• Meadox(R) Surgimed(R) Biopsy Gun II

  Class II

  FDA 510(k) K911635 Active Cleared 20 Jun 1991

• Noprofile Olbert Catheter System

  Class II

  FDA 510(k) K945061 Active Cleared 9 Mar 1995

• Olbert Catheter System with Sidewinder Curve

  Class II

  FDA 510(k) K862550 Active Cleared 2 Sep 1986

• Meadox Surgimed Guide Catheter

  Class II

  FDA 510(k) K860429 Active Cleared 23 Apr 1986

See all devices from Meadox Surgimed, Inc. →

• What types of urological procedures is the No Profile Olbert Catheter System designed to assist with, and how does it reduce patient discomfort?

  The No Profile Olbert Catheter System is specifically designed to facilitate ureteral dilation and catheter placement during procedures like ureteroscopy or stent placement. Its unique design minimizes trauma to the ureteral walls, which helps reduce patient discomfort and potential complications during these interventions. The system is inserted via the urethra and advanced into the ureter, allowing for smoother and more controlled dilation.

• Is the No Profile Olbert Catheter System intended for single-use or repeated use, and what does this mean for clinical workflow?

  The No Profile Olbert Catheter System is supplied as a sterile, single-use device. This means each catheter is intended for one-time use in a single patient, reducing the risk of cross-contamination and ensuring patient safety. Clinically, this simplifies workflow by eliminating the need for reprocessing and allows for immediate use after opening, provided sterility is maintained.

• What sizes or configurations are available for the No Profile Olbert Catheter System, and how do they accommodate different patient anatomies?

  The No Profile Olbert Catheter System comes in multiple sizes and configurations to adapt to varying patient anatomies and procedural needs. While exact sizes are not detailed here, the availability of diverse options ensures compatibility with different ureteral diameters and clinical scenarios, improving flexibility for urologists during dilation or catheter placement.

• How should the No Profile Olbert Catheter System be stored to maintain its sterility and functionality?

  Since the system is sterile and single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediately before use to preserve sterility. Always follow manufacturer instructions for storage conditions to ensure the device remains effective for its intended purpose.

• What regulatory pathway was followed for FDA clearance of the No Profile Olbert Catheter System, and what does this mean for its use in clinical settings?

  The No Profile Olbert Catheter System received FDA clearance through a 510(k) submission, classified as a Class II medical device under regulation 876.5470. The clearance was granted as substantially equivalent to a predicate device, meaning it meets the same performance standards and safety requirements. Clinically, this clearance indicates the device has undergone rigorous review by the FDA and is approved for use in clinical settings like operating rooms or procedural suites for ureteral dilation and catheter placement.