Product code FDS

Device name

Gastroscope And Accessories, Flexible/Rigid

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1500

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

To examine or perform procedures in the stomach. 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).

Source

FDA openFDA device classification dataset