Navarre Percutaneous Biliary Drainage

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

510(k) Number

K955110 ↗

FDA Product Code

FGE

FDA applicant

Navarre Biomedical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Navarre Locking Pigtail Universal Drainage Catheter

  Class I

  FDA 510(k) K951907 Active Cleared 15 May 1995

• Navarre 600 ML Drainage Bag

  Class II

  FDA 510(k) K943663 Active Cleared 8 Sep 1994

• Navarre Biomedical Tip-Locking Drainage Catheters

  Class I

  FDA 510(k) K933600 Active Cleared 28 Mar 1994

• Navarre Percutaneous Access Set

  Class I

  FDA 510(k) K942315 Active Cleared 8 Jul 1994

• Opti-Drain Multi-Use Drainage Catheter

  Class I

  FDA 510(k) K955505 Active Cleared 7 Feb 1996

• Navarre Biomedical Universal Drainage Catheter Set

  Class I

  FDA 510(k) K932391 Active Cleared 27 Jan 1994

See all devices from Navarre Biomedical, Ltd. →

• What clinical settings or procedures is the Navarre Percutaneous Biliary Drainage intended for use in?

  The Navarre Percutaneous Biliary Drainage is specifically designed for use in clinical settings such as endoscopy and interventional radiology. It is intended to facilitate percutaneous biliary drainage, which helps relieve biliary obstruction by draining bile from the liver or gallbladder into the gastrointestinal tract or an external collection system.

• Is the Navarre Percutaneous Biliary Drainage intended for single-use or can it be reused?

  The Navarre Percutaneous Biliary Drainage is supplied as a single-use device. This means it is intended for one-time use only and should not be reused after initial deployment.

• What medical specialties are primarily involved in the use of this device?

  The device is primarily intended for use in the specialties of gastroenterology and urology, as indicated by its regulatory classification and advisory committee designation.

• What is the regulatory route for this device, and how was its clearance determined?

  The Navarre Percutaneous Biliary Drainage was cleared through the FDA’s 510(k) process, specifically under the Traditional pathway. It was determined to be *substantially equivalent* (SESE) to a legally marketed predicate device, meaning its safety and effectiveness were deemed comparable to an existing device already on the market.

• Are there different sizes or models available for this device, and if so, how would one determine the appropriate size?

  While the provided data does not explicitly list specific sizes or models, the device is categorized under FDA product code FGE, which typically includes a range of sizes for biliary drainage applications. Selection of the appropriate size would depend on clinical assessment, such as the diameter of the biliary duct or obstruction, and should be determined by the treating physician based on patient-specific anatomy and procedural needs.