Celerity Chemical Indicator for enspire 3000 CLCSPS
510(k) K240032
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240032 | Date17 Apr 2024 | 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- Withdrawn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, 26 Sep 2026
The Celerity Chemical Indicator for enspire 3000 CLCSPS is a device used to monitor the liquid chemical sterilization process of the enspire 3000 system. It is classified as an indicator for physical/chemical sterilization processes and is intended for routine monitoring.
The device is supplied as part of the enspire 3000 CLCSPS system and is intended for single-use applications. It is regulated under FDA 510(k) clearance and is classified as a Class II device with special controls.
Other devices from Steris Corporation
Questions
AI-generated answers, 26 Sep 2026
What is the Celerity Chemical Indicator for enspire 3000 CLCSPS used for?
It is a device used to monitor the liquid chemical sterilization process of the enspire 3000 system. It is intended for routine monitoring.
Is the Celerity Chemical Indicator for enspire 3000 CLCSPS intended for single use?
Yes, it is intended for single-use applications.
How is the Celerity Chemical Indicator for enspire 3000 CLCSPS supplied?
It is supplied as part of the enspire 3000 CLCSPS system.
What is the regulatory status of the Celerity Chemical Indicator for enspire 3000 CLCSPS?
It is regulated under FDA 510(k) clearance and is classified as a Class II device with special controls.