Extricare 100CC/ 250CC/ 400CC Canisters
by Devon Medical, Inc. 510(k)
Active
510(k) K132252
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132252 | Date27 Sep 2013 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
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.
Other devices from Devon Medical, Inc.
Questions
AI-generated answers, 23 Sep 2026
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.