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

Endoscopic Ultrasound System, Gastroenterology-Urology

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

ODG is the FDA product code for Endoscopic Ultrasound System, Gastroenterology-Urology, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at...". As of , FDA records hold 44 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
ODG
Device name
Endoscopic Ultrasound System, Gastroenterology-Urology
FDA definition
To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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
44
Ingested recalls
10

Clearances, product code ODG

By decision year
44 clearances under product code ODG with a decision year between 1991 and 2026, 2017 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code ODG by decision year
YearClearances
19911
19931
19951
19961
19981
20013
20022
20033
20041
20061
20092
20112
20132
20141
20161
20174
20183
20191
20202
20211
20224
20231
20241
20252
20262

Applicants with the most clearances

Product code ODG
Applicants holding the most 510(k) clearances under product code ODG
ApplicantClearances
PENTAX of America, Inc.9
Boston Scientific Corporation8
Pentax Precision Instrument Corp.7
FUJIFILM Corporation4
Olympus Optical Co., Ltd.3
Micro-Tech (Nanjing) Co., Ltd.2
OLYMPUS Corporation of the Americas2
Olympus Corp.2
Olympus Medical Systems Corp.2
Endosound Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order