ORCClass II
Air Filter Portable Apparatus
General, Plastic Surgery · 21 CFR 878.5070
The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
MDR events0All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances6All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Toul Meditech ABMay 10, 2019
K190027 · SteriStay
- Toul Meditech ABDec 20, 2017
K173349 · Operio
- Surgicube International B.V.Sep 28, 2017
K163455 · SurgiCube
- Toul Meditech ABJul 20, 2016
K153498 · Operio
- Nimbic Systems, Inc.Dec 20, 2013
K123006 · AIR BARRIER SYSTEM (ABS)
- Nimbic Systems, LLCMay 20, 2011
K092801 · ABS BLOWER, ABS NOZZLE, MODEL 1001