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

Endoscopic Guidewire, Gastroenterology-Urology

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

OCY is the FDA product code for Endoscopic Guidewire, Gastroenterology-Urology, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To provide access to gi or gu tract for the purpose of passing or exchanging other accessories". As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
OCY
Device name
Endoscopic Guidewire, Gastroenterology-Urology
FDA definition
To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
43
Ingested recalls
10

Clearances, product code OCY

By decision year
43 clearances under product code OCY with a decision year between 1981 and 2016, 2014 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code OCY by decision year
YearClearances
19811
19891
19901
19912
19933
19942
19961
19973
19991
20011
20021
20032
20041
20051
20062
20071
20083
20091
20122
20134
20145
20153
20161

Applicants with the most clearances

Product code OCY
Applicants holding the most 510(k) clearances under product code OCY
ApplicantClearances
Boston Scientific Corporation5
Wilson-Cook Medical Inc.5
Lake Region Medical4
Neometrics, Inc.3
C.R. Bard Inc2
MEDLINE INDUSTRIES, LP - Northfield2
Flexmedics2
Terumo Corp.2
Terumo Medical Corp.2
Xenolith Medical2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 75 companies shown, in name order