Medical Device Manufacturer · US , Rochester , NY

Getinge/Castle, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1997

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Getinge/Castle, Inc. General Hospital ✕

7 devices

1-7 of 7

Cleared Jun 24, 2002

CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT

General Hospital · 153d

Cleared Mar 20, 2002

MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER

General Hospital · 26d

Cleared Sep 05, 2001

CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND...

General Hospital · 27d

Cleared Jan 02, 2001

CASTLE MODEL 233HC STEAM STERILIZER

General Hospital · 57d

Cleared Feb 16, 2000

CASTLE SERIES 100HC STEAM STERILIZERS

General Hospital · 56d

Cleared Feb 10, 1998

CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)

General Hospital · 167d

Cleared Nov 12, 1997

CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE)

General Hospital · 246d