Meadox(R) Surgimed Olbert Cath Syst for Urology

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

510(k) Number

K904983 ↗

FDA Product Code

EZN

Device Class

Class II

Regulation

21 CFR Part 876.5470

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 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

• Acecut Sutomatic Biopsy System

  Class II

  FDA 510(k) K930201 Active Cleared 9 Jun 1993

See all devices from Meadox Surgimed, Inc. →

• What is the primary purpose of the MEADOX® SURGIMED Olbert Catheter System in urological procedures?

  The MEADOX® SURGIMED Olbert Catheter System is designed specifically for controlled dilation and access within the ureter during urological procedures. It functions as both a ureteral dilator and catheter, allowing for careful expansion of the ureter while providing a pathway for instruments or fluids.

• Is the Olbert Catheter System intended for reuse, or is it meant to be used only once?

  The Olbert Catheter System is supplied as a sterile, single-use device. This means it is intended for one-time use only and should not be reused after a single procedure to maintain patient safety and sterility.

• How should the Olbert Catheter System be stored to ensure it remains sterile?

  The system must be stored according to the manufacturer’s instructions to preserve sterility. Since it is packaged for single-use, it should remain in its original, unopened packaging until ready for use, and kept in a clean, dry environment away from direct sunlight or extreme temperatures.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Olbert Catheter System received FDA clearance through a 510(k) submission, specifically under the Traditional clearance type, with a decision code of SESE (Substantially Equivalent). This means the FDA determined it is substantially equivalent to a legally marketed device in terms of technology and intended use, ensuring it meets safety and effectiveness standards for urological dilation and catheterization procedures.

• Are there multiple sizes or models available for the Olbert Catheter System, and how would I identify the correct one for a procedure?

  The provided data lists multiple FEI numbers (e.g., 3006546082, 3013557562) and registration numbers, which likely correspond to different sizes or variations of the Olbert Catheter System. While the exact sizing details (e.g., French sizes, lengths) aren’t specified here, these identifiers help track regulatory compliance and inventory. For precise sizing, refer to the manufacturer’s product documentation or consult with a Meadox Surgimed representative to select the appropriate model for a patient’s anatomy and procedural needs.