E-VAC

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

Full name

E-Vac(Tm)

510(k) Number

K862875 ↗

FDA Product Code

BTA

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the E-VAC portable aspiration pump used for?

  The E-VAC is designed for use in general and plastic surgery procedures to provide aspiration functionality. It can be operated as either a manual or powered pump, making it versatile for different surgical needs.

• How is the E-VAC supplied and what sizes are available?

  The E-VAC is supplied as a Class II medical device and is available in various sizes as indicated by the multiple registration numbers associated with this device. This range of sizes allows for flexibility in different surgical applications.

• What is the regulatory status of the E-VAC?

  The E-VAC has FDA 510(k) clearance K862875 and is classified as a Class II medical device. It is manufactured by Laerdal California, Inc. and is substantially equivalent to other devices in its class for general and plastic surgery procedures.

• Is the E-VAC single-use or reusable?

  The device data does not specify whether the E-VAC is designed for single-use or multiple uses. As a portable aspiration pump with both manual and powered options, its reusability would depend on the specific model and the manufacturer's instructions for use.