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K Number
K060023
Device Name
ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
Manufacturer
ANGIODYNAMICS, INC.
Date Cleared
2006-03-09

(64 days)

Product Code
FGE
Regulation Number
876.5010
Type
Special
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ANGIODYNAMICS Total Abscession Biliary Drainage Catheter is indicated for percutaneous transhepatic biliary drainage.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ANGIODYNAMICS Total Abscession Biliary Drainage Catheter). It primarily concerns the regulatory approval based on substantial equivalence to a predicate device and states the indications for use.

This document does not contain any information about:

  • Acceptance criteria and reported device performance.
  • Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
  • MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for this specific input.

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.