510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OEWClass II

Tracking, Soft Tissue, Intraoperative

21 CFR 882.4560 / Neurology
FDA source (opens on fda.gov)

OEW is the FDA product code for Tracking, Soft Tissue, Intraoperative, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code reads: "For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OEW
Device name
Tracking, Soft Tissue, Intraoperative
FDA definition
For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code OEW

By decision year
4 clearances under product code OEW with a decision year between 2007 and 2015, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OEW by decision year
YearClearances
20071
20101
20111
20151

Applicants with the most clearances

Product code OEW
Applicants holding the most 510(k) clearances under product code OEW
ApplicantClearances
Pathfinder Therapeutics, Inc.3
Cascination1

Companies listing this code with FDA

Companies whose registered establishments list this code