Porges ERCP Catheters

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

510(k) Number

K896503 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Porges Endoscopic Dormia Extractors, Dormiatriptor

  Class II

  FDA 510(k) K896506 Active Cleared 26 Jan 1990

• Porges Nasobiliary Drain

  Class II

  FDA 510(k) K896376 Active Cleared 22 Jan 1990

• Porges Sclerotherapy Needles

  Class II

  FDA 510(k) K896424 Active Cleared 26 Jan 1990

• Biliary Endoprosthesis for Internal Drainage Set

  Class II

  FDA 510(k) K892383 Active Cleared 4 May 1989

• Modified Pediatric Silicone Foley Catheters

  Class II

  FDA 510(k) K900031 Active Cleared 6 Mar 1990

• Porges Sphincterotomes

  Class II

  FDA 510(k) K896426 Active Cleared 22 Jan 1990

See all devices from Porges Corp. →

• Are the Porges ERCP Catheters reusable or intended for single-use only in clinical settings?

  The Porges ERCP Catheters are explicitly labeled as single-use medical devices. This designation ensures sterility and safety for each procedure, as they are intended for use in sterile clinical settings like endoscopy suites, preventing cross-contamination between patients.

• What medical specialties are primarily associated with the use of these catheters?

  The Porges ERCP Catheters are designed for use in gastroenterology and urology procedures, specifically within the context of endoscopic retrograde cholangiopancreatography (ERCP). These specialties rely on the catheters for diagnostic imaging and therapeutic interventions in the biliary and pancreatic ducts.

• How are these catheters regulated in the U.S., and what does that mean for purchasing or clinical use?

  The Porges ERCP Catheters are regulated under the FDA 510(k) clearance process (with clearance number K896503) and fall under Class II devices (regulation number 876.5010). This means they have undergone a premarket review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet safety and effectiveness standards for clinical use in ERCP procedures.

• Are there any available details on the sizes or technical specifications for these catheters?

  The provided data does not include specific measurements, sizes, or technical specifications for the Porges ERCP Catheters. For precise sizing or technical details, such as diameter, length, or material composition, you would need to consult the manufacturer’s product documentation or contact Porges Corp. directly.