Universal Suction Pump Type EUS

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

510(k) Number

K813312 ↗

FDA Product Code

BTA

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Ameda Neonatal Resuscitation Unit-

  Class II

  FDA 510(k) K832637 Active Cleared 22 Dec 1983

• Ametherm

  Class II

  FDA 510(k) K840526 Active Cleared 30 Apr 1984

• Egnell-Lact B Battery-Operated Breast Pump

  Class II

  FDA 510(k) K844307 Active Cleared 4 Feb 1985

• Egnell Compact, Type Ehv

  Class II

  FDA 510(k) K812020 Active Cleared 20 Oct 1981

• Egnell Universal Suction Pump

  Class II

  FDA 510(k) K853909 Active Cleared 25 Nov 1985

• Pe-01 Electronic Infusion Pump

  Class II

  FDA 510(k) K812898 Active Cleared 2 Dec 1981

See all devices from Egnell, Inc. →

• What is the Universal Suction Pump Type EUS primarily used for?

  The Universal Suction Pump Type EUS is designed for manual or powered suction applications in clinical settings. It removes fluids, infectious materials, or debris from wounds, airways, or respiratory support systems to maintain patient safety and hygiene. This makes it particularly useful in general and plastic surgery procedures where controlled suction is required.

• Is the Universal Suction Pump Type EUS a single-use or reusable device?

  The Universal Suction Pump Type EUS is supplied as a reusable device. This allows for repeated use in clinical environments, provided proper cleaning, maintenance, and sterilization protocols are followed. Reusability helps reduce waste and costs while ensuring consistent performance.

• What regulatory clearance does the Universal Suction Pump Type EUS hold?

  The Universal Suction Pump Type EUS holds FDA 510(k) clearance with the decision labeled as Substantially Equivalent (SESE). This clearance indicates that the device meets regulatory standards for safety and effectiveness, specifically for use in general and plastic surgery procedures as outlined by the FDA’s classification (BTA).

• Are there any specific storage conditions mentioned for the Universal Suction Pump Type EUS?

  The provided data does not include detailed storage conditions for the Universal Suction Pump Type EUS. Clinicians should follow general guidelines for maintaining medical devices, such as keeping the device in a clean, dry environment and protecting it from physical damage or contamination. Always refer to manufacturer instructions for specific storage recommendations.

• Can the Universal Suction Pump Type EUS be used in MRI environments?

  No specific MRI safety information is provided for the Universal Suction Pump Type EUS. If used in or near MRI environments, clinicians must ensure compliance with MRI safety protocols to avoid interference or risks to patients and staff. Always verify compatibility with MRI systems before use.