Loop Retriever

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

510(k) Number

K830802 ↗

FDA Product Code

OCZ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Al Askari Percutaneous Access Needle Holder

  Class I

  FDA 510(k) K851162 Active Cleared 15 Apr 1985

• Van-Tec Pediatric Suprapubic Catheter Set

  Class II

  FDA 510(k) K870555 Active Cleared 10 Mar 1987

• Ureteral Catheter Connecting Tube

  Class II

  FDA 510(k) K820866 Active Cleared 26 Apr 1982

• Van-Tec Disposable Flexible Endoscope

  Class II

  FDA 510(k) K860771 Active Cleared 23 Apr 1986

• Van-Tec Segura Stone Basket W/Protective Sheath

  Class II

  FDA 510(k) K870696 Active Cleared 30 Mar 1987

• Van-Tec Bladder Evacuator

  Class II

  FDA 510(k) K880099 Active Cleared 2 Mar 1988

See all devices from Van-Tec, Inc. →

• What is the Loop Retriever used for in medical procedures?

  The Loop Retriever is designed specifically for endoscopic retrieval of foreign bodies, such as gallstones or ureteral stones, from the biliary or urinary tract. It is manually operated, allowing precise manipulation and extraction of targeted objects during procedures like ERCP (endoscopic retrograde cholangiopancreatography) or ureteroscopy. Its grasping and cutting capabilities enable clinicians to safely remove obstructions without invasive surgery.

• Is the Loop Retriever single-use or reusable?

  The Loop Retriever is a reusable instrument, intended for use in controlled clinical settings such as operating rooms or endoscopy suites. Reusability is achieved through adherence to standard medical device sterilization protocols before each procedure, ensuring safety and compliance with regulatory requirements for reusable endoscopic tools.

• What sterilization methods are recommended for the Loop Retriever?

  The Loop Retriever must be sterilized according to standard medical device protocols prior to each use. While the device data does not specify exact sterilization methods, common practices for reusable endoscopic instruments include steam sterilization (autoclaving) or ethylene oxide gas sterilization. Always follow manufacturer guidelines and facility protocols to maintain sterility and prevent contamination.

• Can the Loop Retriever be used with MRI equipment?

  No, the Loop Retriever is explicitly not indicated for MRI use. This restriction is likely due to potential interference with magnetic fields or safety concerns related to metallic components within the device. Always verify compatibility with imaging modalities before use in clinical settings.

• What regulatory pathway was followed for FDA clearance of the Loop Retriever?

  The Loop Retriever received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This pathway involves demonstrating that the new device is as safe and effective as a legally marketed device that is not an equivalent product. The device is classified under FDA product code OCZ and falls under Class 2 regulatory controls.