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® Ultrasound Disposable Kit (UDK-T) 5006

Name: EndoSound® Ultrasound Disposable Kit (UDK-T) 5006
Brand: EndoSound® Ultrasound Disposable Kit (UDK-T) 5006

EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK…

Registry build 21.09.26

EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 9mm Wall Thickness: 1mm

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® Ultrasound Disposable Kit (UDK-T) 5006
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	2024-01-30

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Handling environment atmospheric pressure 75 to 106 KiloPascal; Handling environment humidity 10 to 95 % RH; Handling environment temperature -10 to 60 °C; Storage environment atmospheric pressure 75 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -10 to 60 °C
Packaging	Box of 10
Sizes	Lumen/inner diameter 9 mm

Catalogue Numbers

Catalogue numbers for EndoSound® Ultrasound Disposable Kit (UDK-T) 5006
Catalogue number	Size	Status
5006	Lumen/Inner Diameter 9 mm	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.