Olbert Catheter System for Biliary Tract Dilatatio

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

510(k) Number

K851647 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

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 is the Olbert Catheter System for Biliary Tract Dilatation used for?

  The Olbert Catheter System for Biliary Tract Dilatation is intended for use in the biliary tract to facilitate dilatation, functioning as a stent, drain, or dilator for biliary ducts in gastroenterology and urology settings.

• How is the Olbert Catheter System supplied and by whom?

  The Olbert Catheter System is supplied by Meadox Surgimed, Inc., located at 112 Bauer Dr., Oakland, NJ 07436, as indicated in the device registration and authorization records.

• What regulatory pathway was used for the Olbert Catheter System?

  The Olbert Catheter System received FDA 510(k) clearance under k-number K851647, with a decision date of July 3, 1985, and was classified as substantially equivalent to a predicate device.