Porges Sclerotherapy Needles

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

510(k) Number

K896424 ↗

FDA Product Code

FBK

Device Class

Class II

Regulation

21 CFR Part 876.1500

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 ERCP Catheters

  Class II

  FDA 510(k) K896503 Active Cleared 30 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. →

• What are the Porges Sclerotherapy Needles used for?

  These needles are designed specifically for endoscopic procedures in gastroenterology and urology. They deliver sclerosing agents to induce fibrosis and occlusion of targeted blood vessels, commonly used to treat vascular malformations, hemorrhoids, or varicose veins. Their precise design ensures controlled injection during minimally invasive interventions.

• Are the Porges Sclerotherapy Needles single-use or reusable?

  The Porges Sclerotherapy Needles are supplied as single-use devices. This ensures sterility and safety for each procedure, adhering to regulatory standards for endoscopic instruments. Reuse is not recommended or supported by the manufacturer.

• What regulatory clearance does the Porges Sclerotherapy Needles hold?

  The Porges Sclerotherapy Needles have received FDA 510(k) clearance under the product code FBK, classified as a Class II device. The clearance (K896424) was granted in 1990, affirming their substantial equivalence to a predicate device under the Special Controls for Class II devices.

• How are the Porges Sclerotherapy Needles supplied?

  The needles are supplied as sterile, single-use devices. While specific packaging details are not provided, they are intended for professional medical use in controlled clinical settings. Sterility is maintained to ensure safe and effective use in endoscopic procedures.

• Are there different sizes or models available for the Porges Sclerotherapy Needles?

  The provided data does not specify distinct sizes or models beyond the general classification as endoscopic injection needles. However, the device is categorized under FDA product code FBK, which typically includes a range of needle gauges or lengths tailored for various endoscopic applications. For exact specifications, consult the manufacturer’s documentation.