Eagle 2000 Sterilizer
510(k) K781684
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781684 | Date24 Oct 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Sterilizer, Eagle 2000
- 510(k) Number
- FDA Product Code
- FLE
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6880
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Eagle 2000 is a steam sterilizer designed for use in general hospital settings. It functions as an autoclave to provide sterilization of medical equipment.
This device is regulated as a Class 2 medical device under FDA 510K authorization. It is available in various models, including 2011, 2021, 2013, 2023, 2031, 2041, 2051, 2033, 2043, and 2053.
Other devices from American Sterilizer Co.
Questions
AI-generated answers, 24 Sep 2026
What is the primary purpose of the Eagle 2000?
The Eagle 2000 is a steam sterilizer, or autoclave, designed specifically for use in general hospital settings to provide sterilization of medical equipment.
Which models are available for the Eagle 2000?
The device is available in a range of models to suit different facility needs, including models 2011, 2021, 2013, 2023, 2031, 2041, 2051, 2033, 2043, and 2053.
What is the regulatory status of this sterilizer?
The Eagle 2000 is regulated as a Class 2 medical device and has received FDA 510K authorization under the number K781684.