ORC · Class II · 21 CFR 878.5070

FDA Product Code ORC: Air Filter Portable Apparatus

The Sytem Is Intended To Control The Surgical Environment To Prevent Bacterial Contamination During Surgical Procedures.

Leading manufacturers include Toul Meditech AB, Surgicube International B.V. and Nimbic Systems, Inc..

6
Total
6
Cleared
294d
Avg days
2011
Since

FDA 510(k) Cleared Air Filter Portable Apparatus Devices (Product Code ORC)

6 devices
1–6 of 6
Cleared May 10, 2019
SteriStay
K190027
Toul Meditech AB
General & Plastic Surgery · 123d
Cleared Dec 20, 2017
Operio
K173349
Toul Meditech AB
General Hospital · 56d
Cleared Sep 28, 2017
SurgiCube
K163455
Surgicube International B.V.
General Hospital · 293d
Cleared Jul 20, 2016
Operio
K153498
Toul Meditech AB
General Hospital · 226d
Cleared Dec 20, 2013
AIR BARRIER SYSTEM (ABS)
K123006
Nimbic Systems, Inc.
General Hospital · 449d

About Product Code ORC - Regulatory Context