Panendoscope (Gastroduodenoscope)
The Panendoscope (Gastroduodenoscope) (product code FAK) is an endoscopic device used to visualize and perform procedures in the upper gastrointestinal tract, including the esophagus, stomach, and duodenum. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807).
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Basic Information
- Product Code
- FAK
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.