FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
K Number: K230930
·
Decision Jun 30, 2023
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
57
Applicant Total
169
Review Days
88
Basic Information
- Device Name
- enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
- K Number
- K230930
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERIS Corporation
- Date Received
- April 3, 2023
- Decision Date
- June 30, 2023
- Product Code
- FEB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FEB | Accessories, Cleaning, For Endoscope | FDA class 2 | Gastroenterology, Urology |
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