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Percupump II

by E-Z-Em, Inc. 510(k)

Active United States

510(k) K932055

Overview

The Percupump II is an extra-luminal infusion or syringe pump designed for controlled delivery of fluids in medical procedures. Classified as a Class II device under FDA regulations, it is intended for use in gastroenterology and urology applications, facilitating precise fluid administration during percutaneous interventions.

This device is supplied as a reusable medical instrument and requires appropriate maintenance as outlined in manufacturer documentation. It is not intended for MRI environments and must be stored in a clean, dry environment to ensure functionality. The Percupump II holds an FDA 510(k) clearance (K932055) under the product code FIH, with a decision date of March 21, 1995, and is regulated under the regulation number 876.5820.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932055 Date21 Mar 1995ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 5 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FIH
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Percupump II used for?

    The Percupump II is designed for controlled delivery of fluids during percutaneous interventions in gastroenterology and urology. It ensures precise fluid administration, which is critical for procedures requiring accurate dosing or pressure control, such as certain endoscopic or urological treatments.

  • Is the Percupump II a single-use or reusable device?

    The Percupump II is a reusable medical instrument. Like other reusable devices, it requires regular maintenance and cleaning as specified in the manufacturer’s documentation to ensure safety, functionality, and compliance with medical standards.

  • Can the Percupump II be used in an MRI environment?

    No, the Percupump II is not intended for use in MRI environments. Magnetic resonance imaging involves strong magnetic fields and radio waves, which could interfere with the device’s operation or pose safety risks. Always verify device compatibility with the specific MRI system before use.

  • How should the Percupump II be stored?

    The Percupump II must be stored in a clean, dry environment to maintain its functionality. Proper storage prevents contamination, corrosion, or damage that could compromise performance or sterility if the device is prepared for use in sterile procedures.

  • What regulatory clearance does the Percupump II hold?

    The Percupump II holds an FDA 510(k) clearance (K932055) under the product code FIH, classified as a Class II device. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness in its intended use.