DeviceClearance

Product code PEC— General Hospital

GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM

Classification name
Sterilizer Automated Loading System
Device class
Class 2
Regulation
21 CFR 880.6880
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PEC under 21 CFR 880.6880, via openFDA

Market context for product code PEC

FDA has cleared 1 device under product code PEC, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PEC

Recent clearances under product code PEC

Data sourced from openFDA. This site is unofficial and independent of the FDA.