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

Air Filter Portable Apparatus

21 CFR 878.5070 / General, Plastic Surgery
FDA source (opens on fda.gov)

ORC is the FDA product code for Air Filter Portable Apparatus, a class II device type, regulated under 21 CFR 878.5070. FDA's definition for this code reads: "The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ORC
Device name
Air Filter Portable Apparatus
FDA definition
The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code ORC

By decision year
6 clearances under product code ORC with a decision year between 2011 and 2019, 2017 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ORC by decision year
YearClearances
20111
20131
20161
20172
20191

Applicants with the most clearances

Product code ORC
Applicants holding the most 510(k) clearances under product code ORC
ApplicantClearances
Toul Meditech AB3
Nimbic Systems, Inc.2
Surgicube International B.V.1

Companies listing this code with FDA

Companies whose registered establishments list this code