FAK

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Panendoscope (Gastroduodenoscope)

Device class

Class II (moderate risk)

Regulation

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

FDA definition

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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).

Adverse events (MAUDE)

2008: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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