Steoility Testing Vessel
510(k) K771146
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771146 | Date26 Aug 1977 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- JOJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.2800
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Steoility Testing Vessel is a device classified as an Indicator, Physical/Chemical Sterilization Process, used to assess the sterility of materials or environments through chemical or physical means. It serves as a controlled vessel for testing the effectiveness of sterilization processes, ensuring that residual contaminants or microbial agents are detected and validated.
This vessel is supplied as a reusable item and is intended for use in laboratory or industrial settings where sterilization validation is required. It is not specified as MRI-safe, and no details regarding single-use or sterile packaging are provided. The device was cleared under FDA 510(k) K771146 with a classification under Regulation 880.2800, falling under the General Hospital medical specialty category. No additional regulatory markings or certifications beyond the FDA clearance are mentioned.
Other devices from Tower Products, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Steoility Testing Vessel in a laboratory or industrial setting?
The Steoility Testing Vessel is designed to assess the effectiveness of sterilization processes by serving as a controlled environment for testing. It helps detect residual contaminants or microbial agents, ensuring that sterilization validation meets required standards for materials or environments.
Is the Steoility Testing Vessel intended for single-use or can it be reused?
The device is explicitly described as a reusable item, meaning it is meant to be cleaned and used multiple times in laboratory or industrial settings for sterilization validation testing.
How was the Steoility Testing Vessel cleared by the FDA, and what does this mean for its use?
The device was cleared under an FDA 510(k) submission (K771146) with a classification of 'Substantially Equivalent' and falls under the General Hospital medical specialty category. This means it was determined to be as safe and effective as a legally marketed device that served as its predicate, allowing it to be legally marketed in the U.S. for its intended use in sterilization validation.
Are there any specific storage requirements mentioned for the Steoility Testing Vessel?
The provided data does not specify any particular storage requirements for the Steoility Testing Vessel, such as temperature, humidity, or handling instructions. However, since it is reusable, proper cleaning and maintenance procedures should be followed to ensure its continued effectiveness and longevity.