Porges Endoscopic Dormia Extractors, Dormiatriptor

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

510(k) Number

K896506 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 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

• 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 medical specialties primarily use the Porges Endoscopic Dormia Extractors, Dormiatriptor, and why are they relevant to those fields?

  The Porges Endoscopic Dormia Extractors are primarily used in gastroenterology and urology specialties. These fields rely on the device for endoscopic procedures like ERCP (endoscopic retrograde cholangiopancreatography) or direct endoscopic interventions to remove biliary stones or obstructions. Its design minimizes tissue trauma during extraction, making it critical for clearing blockages in the biliary tree while ensuring patient safety during minimally invasive procedures.

• Are the Porges Endoscopic Dormia Extractors reusable, or are they intended for single-use only?

  The Porges Endoscopic Dormia Extractors are explicitly intended for single-use applications in controlled clinical settings. This design choice aligns with sterile procedure requirements and reduces the risk of cross-contamination or device degradation between patients.

• How are the Porges Endoscopic Dormia Extractors supplied, and what should clinicians expect regarding sterility?

  The device is supplied sterile as part of its packaging, ensuring readiness for immediate use in endoscopic procedures. Since it’s classified under FDA regulation 876.5010 for biliary drains/stents, sterility is a key feature to maintain procedural safety and compliance with medical standards.

• What regulatory pathway was followed for FDA clearance of the Porges Endoscopic Dormia Extractors, and what does that mean for clinicians?

  The device received FDA 510(k) clearance (K896506) under the Traditional pathway in 1990, with a determination of *Substantially Equivalent (SESE)* to a predicate device. This means the FDA evaluated it against an existing approved product and confirmed it met safety and effectiveness standards for its intended use in biliary stone extraction during endoscopic procedures.

• What types of obstructions or conditions are these extractors designed to address in the biliary system?

  The Porges Endoscopic Dormia Extractors are specifically designed to remove biliary stones (calculi) or foreign bodies within the biliary ducts during endoscopic procedures. Their construction allows precise extraction while minimizing trauma to surrounding tissues, making them suitable for clearing obstructions in the biliary tree during ERCP or direct endoscopic interventions.