FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
K Number: K243433
·
Decision Dec 2, 2024
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
57
Applicant Total
169
Review Days
27
Basic Information
- Device Name
- enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System
- K Number
- K243433
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERIS Corporation
- Date Received
- November 5, 2024
- Decision Date
- December 2, 2024
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FEB), ordered by most recent decision date.
CORIS System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
System 83 Revolve Endoscope Washer/Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCOPE BUDDY PLUS Endoscope Flushing Aid
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endoscope Reprocessor OER-Elite
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
System 83 Plus Washer/Disinfector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by STERIS Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 | May 2, 2025 | Substantially Equivalent |
| K243876 | VERIFY STEAM Integrating Indicator | Apr 25, 2025 | Substantially Equivalent |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | Apr 18, 2025 | Substantially Equivalent |
| K250061 | Celerity Incubator | Feb 6, 2025 | Substantially Equivalent |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) | Feb 6, 2025 | Substantially Equivalent |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | Dec 4, 2024 | Substantially Equivalent |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | Oct 11, 2024 | Substantially Equivalent |
| K240274 | PADLOCK CLIP EFTR Kit (00713229) | Sep 17, 2024 | Substantially Equivalent |
| K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | Apr 17, 2024 | Substantially Equivalent |
| K240352 | Defendo Single Use Cleaning Adapter for Olympus Endoscopes | Mar 6, 2024 | Substantially Equivalent |