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

Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula

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

ODD is the FDA product code for Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To identify stones, tumors, or narrowing in the biliary tree". As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ODD
Device name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
FDA definition
To identify stones, tumors, or narrowing in the biliary tree.
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
18
Ingested recalls
0

Clearances, product code ODD

By decision year
18 clearances under product code ODD with a decision year between 1980 and 2025, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ODD by decision year
YearClearances
19801
19821
19831
19841
19851
19891
19911
19952
19961
19972
20012
20071
20181
20201
20251

Applicants with the most clearances

Product code ODD
Applicants holding the most 510(k) clearances under product code ODD
ApplicantClearances
C.R. Bard Inc2
United States Endoscopy Group, Inc.2
Wilson-Cook Medical Inc.2
Act Medical, Inc.1
American Endoscopy, Inc.1
Boston Scientific Corporation1
Hobbs Medical, Inc.1
Microvasive1
Mill-Rose Laboratory1
OLYMPUS Corporation of the Americas1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order