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Product code FGB

Device name
Ureteroscope 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 perform various diagnostic and therapeutic procedures within the urinary tract. 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