What is FDA product code ODG?

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).

Ultrasound Gastroscope · Endoscopic Ultrasound System, Gastroenterology-Urology → Gastroenterology & Urology

Name: Ultrasound Gastroscope
Brand: Ultrasound Gastroscope

1manufacturer

2catalogue numbers in this listing

6510(k) clearances naming this product code

3recalls on this code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code ODG
Manufacturer	City	Province	Registered as	Device types
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49

Record

Regulatory record for Ultrasound Gastroscope
Listed by	Pentax of America, Inc., United States
FDA product code	ODG
Device type	Endoscopic Ultrasound System, Gastroenterology-Urology
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2017-04-06
Record revised	2026-04-22 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide, High-level Disinfectant
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Ultrasound Gastroscope
Catalogue number	Size	Status
EG-3670URK		In distribution
EG-3870UTK		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pentax	Hoya Corporation	22
Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)	Micro-Tech (Nanjing) Co., Ltd.	12
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)	Micro-Tech (Nanjing) Co., Ltd.	6
Pentax Medical	Hoya Corporation	6
Water-resistant Cap	Olympus Medical Systems Corp.	6
Expect	Boston Scientific Corporation	4
Ultrasonic Probe	Olympus Medical Systems Corp.	4
BALLOON3	Olympus Medical Systems Corp.	3
Acquire	Boston Scientific Corporation	3
Evis-EUS Image Cable	Olympus Medical Systems Corp.	3
Expect Slimline SL	Boston Scientific Corporation	3
Evis Exera II Ultrasound Gastrovideoscope	Olympus Medical Systems Corp.	2

Showing 12 of 52. All products under Endoscopic Ultrasound System, Gastroenterology-Urology

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K203166	2020-12-30
K200090	2020-07-23
K182004	2018-08-21
K162447	2017-04-13
K130206	2013-03-20
K130247	2013-03-20

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2017-05-23	Class II	Error in labeling	Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in	US: 118 units	2020-05-21
2017-05-23	Class II	Error in labeling	Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in	US: 116 units	2020-05-21
2016-04-06	Class II	Device Design	Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.	819 units	2017-07-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Ultrasound Gastroscope