510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PECClass II

Sterilizer Automated Loading System

21 CFR 880.6880 / General Hospital
FDA source (opens on fda.gov)

PEC is the FDA product code for Sterilizer Automated Loading System, a class II device type, regulated under 21 CFR 880.6880. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PEC
Device name
Sterilizer Automated Loading System
FDA 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.
Regulation
21 CFR 880.6880
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code PEC

By decision year
1 clearance under product code PEC with a decision year between 2013 and 2013, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PEC by decision year
YearClearances
20131

Applicants with the most clearances

Product code PEC
Applicants holding the most 510(k) clearances under product code PEC
ApplicantClearances
Getinge Sourcing, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code