Sterilizer Automated Loading System
The Sterilizer Automated Loading System is a general hospital device providing automated loading and unloading of surgical instruments requiring sterilization, designed to increase hospital workflow efficiency and reduce the risk of manual handling errors. It falls under the General Hospital medical specialty and is classified as a Class 2 device under regulation 880.6880, requiring 510(k) premarket notification. Automation of the sterilization loading process supports consistent and reproducible sterilization outcomes in central sterile supply departments. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PEC
- Device Class
- FDA class 2
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K120532 | GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM | May 02, 2013 | Substantially Equivalent | Getinge Sourcing, LLC |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.