Product code ORC— General, Plastic Surgery

Operio

Classification name: Air Filter Portable Apparatus
Device class: Class 2
Regulation: 21 CFR 878.5070
Advisory panel: General, Plastic Surgery
Total cleared: 6
First cleared: 2011-05-20
Most recent: 2019-05-10

FDA classification definition

“The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.”
— U.S. Food and Drug Administration, device classification record for product code ORC under 21 CFR 878.5070, via openFDA

Market context for product code ORC

FDA has cleared 6 devices under product code ORC between 2011 and 2019, filed by 4 applicant companies. 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.

Clearances per year

20191 clearance
20172 clearances
20161 clearance
20131 clearance
20111 clearance

Top applicants under product code ORC

Recent clearances under product code ORC

K190027 — SteriStayToul Meditech AB·2019-05-10
K173349 — OperioToul Meditech AB·2017-12-20
K163455 — SurgiCubeSurgicube International B.V.·2017-09-28
K153498 — OperioToul Meditech AB·2016-07-20
K123006 — AIR BARRIER SYSTEM (ABS)Nimbic Systems, Inc.·2013-12-20
K092801 — ABS BLOWER, ABS NOZZLE, MODEL 1001Nimbic Systems, LLC·2011-05-20

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