K120532 is an FDA 510(k) clearance for the GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM. This device is classified as a Sterilizer Automated Loading System (Class II - Special Controls, product code PEC).
Submitted by Getinge Sourcing, LLC (Rochester, US). The FDA issued a Cleared decision on May 2, 2013, 435 days after receiving the submission on February 22, 2012.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880. Provides Automated Loading And Unloading Of Instruments Requiring Sterilization For Increasing Hospital Work Flow Efficiencies. The System Consists Of A User Interface, Loading Conveyor, Load Transport Shuttles, Unloading Conveyor To Be Used As An Accessory To A Sterilizer..
| 510(k) Number | K120532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2012 |
| Decision Date | May 02, 2013 |
| Days to Decision | 435 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PEC — Sterilizer Automated Loading System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |
| Definition | Provides Automated Loading And Unloading Of Instruments Requiring Sterilization For Increasing Hospital Work Flow Efficiencies. The System Consists Of A User Interface, Loading Conveyor, Load Transport Shuttles, Unloading Conveyor To Be Used As An Accessory To A Sterilizer. |