Medical Device Manufacturer · US , Rochester , NY

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

9 submissions · 9 cleared · Since 1997

Recent clearances: CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT, MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER, CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

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

2 devices

1-2 of 2

Cleared Nov 08, 1999

CASTLE SURGICAL LIGHT, MODEL 3000

General & Plastic Surgery · 42d

Cleared Mar 03, 1998

GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT

General & Plastic Surgery · 125d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 07, 2026