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Extricare 100CC/ 250CC/ 400CC Canisters

by Devon Medical, Inc. 510(k)

Active United States

510(k) K132252

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK132252 Date27 Sep 2013ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Overview

AI-generated summary, 23 Sep 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 100cc/ 250cc/ 400cc Canisters are a Negative Pressure Wound Therapy Powered Suction Pump. This device is used for wound therapy.

The device is supplied in sizes 100cc, 250cc, and 400cc canisters. It is classified as a class 2 device with the regulation number 878.4780. The device has been cleared with the FDA 510K authorization.

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Questions

AI-generated answers, 23 Sep 2026

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

  • What sizes are the Extricare Canisters available in?

    The Extricare Canisters are supplied in sizes 100cc, 250cc, and 400cc.

  • What is the Extricare Canister device used for?

    The Extricare Canister is used for wound therapy, utilizing negative pressure wound therapy powered suction pump technology.

  • Is the Extricare Canister a single-use or reusable device?

    The description does not specify whether the Extricare Canister is single-use or reusable, but it is classified as a class 2 device.

  • What is the regulatory classification of the Extricare Canister?

    The Extricare Canister is classified as a class 2 device with the regulation number 878.4780.