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ExtriCARE 1000 Negative Pressure Wound Therapy System

by Alleva Medical Devices

510(k) K251646

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251646 Date3 Oct 2025ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OMP
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ExtriCARE 1000 Negative Pressure Wound Therapy System is a medical device used for negative pressure wound therapy. It is designed to remove wound exudates, infectious materials, and tissue debris from the wound bed.

The ExtriCARE 1000 system is a portable unit that can be set to different vacuum settings and modes. It is intended for use in wounds with low to medium levels of exudate and can be used for single or multiple patients. The device has a regulation number of 878.4780 and is classified as a class 2 device.

Other devices from Alleva Medical Devices

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the extriCARE 1000 used for?

    The extriCARE 1000 is used for negative pressure wound therapy to remove wound exudates, infectious materials, and tissue debris from the wound bed.

  • Is the extriCARE 1000 suitable for single or multiple patients?

    The extriCARE 1000 can be used for single or multiple patients, making it a versatile option for various clinical settings.

  • What are the vacuum settings and modes of the extriCARE 1000?

    The extriCARE 1000 has adjustable vacuum settings and modes, allowing for customized treatment of low to medium exudate wounds.

  • What is the regulatory classification of the extriCARE 1000?

    The extriCARE 1000 is classified as a class 2 device with a regulation number of 878.4780.