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

Endoscopic Contamination Prevention Sheath

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

ODB is the FDA product code for Endoscopic Contamination Prevention Sheath, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To protect an endoscope from contamination by providing a barrier between the body and the endoscope". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ODB
Device name
Endoscopic Contamination Prevention Sheath
FDA definition
To protect an endoscope from contamination by providing a barrier between the body and the endoscope.
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
5
Ingested recalls
0

Clearances, product code ODB

By decision year
5 clearances under product code ODB with a decision year between 1994 and 2019, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ODB by decision year
YearClearances
19941
20061
20081
20161
20191

Applicants with the most clearances

Product code ODB
Applicants holding the most 510(k) clearances under product code ODB
ApplicantClearances
GI Scientific LLC1
Karl Storz Endoskop GmbH1
Lumenr, LLC1
Minos Medical1
Olympus Medical Systems Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code