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

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

OCS is the FDA product code for Endoscopic Video Imaging System/Component, Gastroenterology-Urology, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To allow for visualization of body cavities through an endoscope by projecting images to a monitor". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
OCS
Device name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
FDA definition
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code OCS

By decision year
1 clearance under product code OCS with a decision year between 2010 and 2010, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OCS by decision year
YearClearances
20101

Applicants with the most clearances

Product code OCS
Applicants holding the most 510(k) clearances under product code OCS
ApplicantClearances
STRYKER Communications, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code