Getinge/Castle, Inc.
Rochester, NY, US
Getinge/Castle, Inc. appears in FDA device records in Rochester, NY. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Getinge/Castle, Inc. between 1997 and 2002. The busiest year on record is 1998, with 2. The most recent is 2002, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K020205 | CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT | FRC | Substantially Equivalent | |
| K020590 | MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER | FLE | Substantially Equivalent | |
| K012573 | CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC | FLE | Substantially Equivalent | |
| K003441 | CASTLE MODEL 233HC STEAM STERILIZER | FLE | Substantially Equivalent | |
| K994314 | CASTLE SERIES 100HC STEAM STERILIZERS | FLE | Substantially Equivalent | |
| K993242 | CASTLE SURGICAL LIGHT, MODEL 3000 | FSY | Substantially Equivalent | |
| K974084 | GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT | FSY | Substantially Equivalent | |
| K973225 | CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE) | FLE | Substantially Equivalent | |
| K970907 | CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) | FLE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0908-03 | Model 8666 Washer/Disinfector with holding tank heater option. Firm on label is Getinge Disinfection AB, Vaxjo, Sweden. | Hot water may splash from the washer chamber creating a burn hazard. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain