Company ยท US
Getinge/Castle, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2002. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2002 | K020205 | CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT Getinge/Castle, Inc. | FRC |
| Mar 20, 2002 | K020590 | MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER Getinge/Castle, Inc. | FLE |
| Sep 5, 2001 | K012573 | CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC Getinge/Castle, Inc. | FLE |
| Jan 2, 2001 | K003441 | CASTLE MODEL 233HC STEAM STERILIZER Getinge/Castle, Inc. | FLE |
| Feb 16, 2000 | K994314 | CASTLE SERIES 100HC STEAM STERILIZERS Getinge/Castle, Inc. | FLE |
| Nov 8, 1999 | K993242 | CASTLE SURGICAL LIGHT, MODEL 3000 Getinge/Castle, Inc. | FSY |
| Mar 3, 1998 | K974084 | GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT Getinge/Castle, Inc. | FSY |
| Feb 10, 1998 | K973225 | CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) Getinge/Castle, Inc. | FLE |
| Nov 12, 1997 | K970907 | CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) Getinge/Castle, Inc. | FLE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2003 | Getinge/Castle, Inc. Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden. Terminated |
MEC | K920413 |