Sauter AG is one of 134 FDA 510(k) medical device manufacturers from Switzerland in the dataset, ranked by real submission volume.
Sauter AG - FDA 510(k) Cleared Devices
Recent clearances: BELIMED STEAM STERILIZER MST-H, BELIMED STEAM STERILIZER MST-V, BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9
5
Total
5
Cleared
0
Denied
Sauter AG, is a building automation and controls company with a manufacturing facility in Sulgen (Tg), Switzerland. The company specializes in products and software for facility management, room automation, and intelligent climate control systems.
Sauter AG received 5 FDA 510(k) clearances from 5 total submissions, with all cleared devices in the General Hospital category. The company's regulatory activity spans from 2002 to 2015. All submissions resulted in clearances with no denials on record. The company is currently inactive in the FDA 510(k) database, with no new clearances since 2015.
Sauter AG's FDA-cleared portfolio consisted of BELIMED steam sterilizer systems, including multiple models and series variants designed for hospital sterilization applications. These devices represent the company's historical focus on medical device manufacturing for general hospital use.
For detailed information on device names, product codes, and specific clearance dates, review the complete 510(k) submission history in the FDA database.
Regulatory submissions have been managed by Tuv America, Inc. and Tuv Sud America, Inc..
FDA 510(k) Regulatory Record - Sauter AG
5 devices
Cleared
Jun 17, 2015
BELIMED STEAM STERILIZER MST-H
General Hospital
341d
Cleared
Mar 15, 2011
BELIMED STEAM STERILIZER MST-V
General Hospital
83d
Cleared
Mar 08, 2006
BELIMED STEAM STERILIZER TOP 5000, MODEL 5-5-9
General Hospital
26d
Cleared
Feb 02, 2004
BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8
General Hospital
84d
Cleared
Jun 26, 2002
BELIMED STEAM STERILIZER, MODEL TOP 5000
General Hospital
69d