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

Endoscopic Storage Cover

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

OCU is the FDA product code for Endoscopic Storage Cover, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OCU
Device name
Endoscopic Storage Cover
FDA definition
To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.
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
6
Ingested recalls
1

Clearances, product code OCU

By decision year
6 clearances under product code OCU with a decision year between 1994 and 2021, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OCU by decision year
YearClearances
19941
19951
20031
20191
20201
20211

Applicants with the most clearances

Product code OCU
Applicants holding the most 510(k) clearances under product code OCU
ApplicantClearances
Acmi Corporation1
Fibertech Instruments, Inc.1
GA Health Company Limited1
Meditech Endoscopy Ltd1
STERIS Corporation1
United States Endoscopy Group, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code