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).

Gastroenterology & Urology › DiagnosticEndoscopic Ultrasound System, Gastroenterology-Urology

EndoSound® Coax Transducer Extension Connector (TEC)

Name: EndoSound® Coax Transducer Extension Connector (TEC)
Brand: EndoSound® Coax Transducer Extension Connector (TEC)

The EndoSound Coax Transducer Extension Connector (TEC) includes the electrical connectors and cable between the EVSScanner and the EVS Probe.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

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 EndoSound® Coax Transducer Extension Connector (TEC)
Listed by	Endosound Inc, United States
FDA product code	ODG
Device type	Endoscopic Ultrasound System, Gastroenterology-Urology
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Complaint-file establishment, Manufacturer
510(k)	K232518
Record published	2026-06-01

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment atmospheric pressure 75 to 106 KiloPascal; Storage environment atmospheric pressure 75 to 106 KiloPascal; Handling environment humidity 10 to 95 % RH; Storage environment humidity 10 to 95 % RH; Storage environment temperature -10 to 60 °C; Handling environment temperature -10 to 60 °C

Catalogue Numbers

Catalogue numbers for EndoSound® Coax Transducer Extension Connector (TEC)
Catalogue number	Size	Status
5104		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
K232518	2023-12-27

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.