FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC
K Number: K012573
·
Decision Sep 5, 2001
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
179
Applicant Total
9
Review Days
27
Basic Information
- Device Name
- CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC
- K Number
- K012573
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GETINGE/CASTLE, INC.
- Date Received
- August 9, 2001
- Decision Date
- September 5, 2001
- Product Code
- FLE
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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Other Clearances by GETINGE/CASTLE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K020205 | CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT | Jun 24, 2002 | Substantially Equivalent |
| K020590 | MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER | Mar 20, 2002 | Substantially Equivalent |
| K003441 | CASTLE MODEL 233HC STEAM STERILIZER | Jan 2, 2001 | Substantially Equivalent |
| K994314 | CASTLE SERIES 100HC STEAM STERILIZERS | Feb 16, 2000 | Substantially Equivalent |
| K993242 | CASTLE SURGICAL LIGHT, MODEL 3000 | Nov 8, 1999 | Substantially Equivalent |
| K974084 | GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT | Mar 3, 1998 | Substantially Equivalent |
| K973225 | CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) | Feb 10, 1998 | Substantially Equivalent |
| K970907 | CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) | Nov 12, 1997 | Substantially Equivalent |