ACKRAD ERCP Contrast Delivery Set

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

510(k) Number

K915813 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Ackrad Endotracheal Tube Introducing Guide

  Class I

  FDA 510(k) K844557 Active Cleared 17 Dec 1984

• Nicos (Non-Invasive Cardiac Output System)

  Class I

  FDA 510(k) K904499 Active Cleared 1 Jul 1991

• Ackrad Bronchitrac

  Class I

  FDA 510(k) K822398 Active Cleared 4 Oct 1982

• Modified Infant Nasal Cannulae Assembly

  Class II

  FDA 510(k) K895031 Active Cleared 30 Oct 1989

• Ackrad Hysterosalpingography Set

  Class II

  FDA 510(k) K842231 Active Cleared 19 Sep 1984

• N-D0-Sure

  Class I

  FDA 510(k) K811185 Active Cleared 2 Jun 1981

See all devices from Ackrad Laboratories →

• What is the primary purpose of the ACKRAD ERCP Contrast Delivery Set during an ERCP procedure?

  The ACKRAD ERCP Contrast Delivery Set is specifically designed to facilitate the precise delivery of contrast media into the biliary or pancreatic ducts. This enhances radiographic visualization during ERCP procedures, aiding both diagnostic and therapeutic interventions by improving the clarity of imaging for the ducts involved.

• Is the ACKRAD ERCP Contrast Delivery Set intended for reuse in clinical settings?

  No, the ACKRAD ERCP Contrast Delivery Set is explicitly intended for single-use only in clinical settings. This ensures sterility and safety for each procedure, as it is supplied sterile and must not be reused.

• How should the ACKRAD ERCP Contrast Delivery Set be stored to maintain its integrity?

  The device must be stored according to the manufacturer’s instructions to preserve sterility and functionality. Since it is sterile upon packaging and intended for single-use, improper storage—such as exposure to moisture, extreme temperatures, or physical damage—could compromise its sterility or performance.

• Can the ACKRAD ERCP Contrast Delivery Set be used in an MRI environment?

  No, the ACKRAD ERCP Contrast Delivery Set is non-MRI-compatible. This means it should not be used or placed in an MRI scanner, as it could pose risks to patients or interfere with imaging equipment.

• What regulatory pathway was followed for FDA clearance of this device, and when was it granted?

  The ACKRAD ERCP Contrast Delivery Set received FDA 510(k) clearance (K915813) under the Traditional 510(k) pathway, with a decision date of March 11, 1992. The device was determined to be substantially equivalent to a legally marketed predicate and falls under FDA classification 876.5010 for Stents, Drains, and Dilators for the Biliary Ducts.