Who is the manufacturer of HORIZONS ERCP CANNULA?

Horizons Intl. Corp. submitted the Traditional clearance for HORIZONS ERCP CANNULA (K002235).

What is the FDA product code for HORIZONS ERCP CANNULA?

FGE. It is classified under 21 CFR 876.5010 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for HORIZONS ERCP CANNULA?

510(k) clearance (submission type: Traditional).

HORIZONS ERCP CANNULA

K002235 · Horizons Intl. Corp. · FGE · Jan 23, 2001 · Gastroenterology, Urology

Device Facts

Record ID	K002235
Device Name	HORIZONS ERCP CANNULA
Applicant	Horizons Intl. Corp.
Product Code	FGE · Gastroenterology, Urology
Decision Date	Jan 23, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5010
Device Class	Class 2

Regulatory Classification

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.

Special Controls

*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.