510(k) K223295
K223295 is an FDA 510(k) premarket notification submitted by Fujifilm Corporaton for the device "Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D". The FDA issued a decision of Substantially Equivalent on January 11, 2023. The device falls under product code FDA (Enteroscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Fujifilm Corporaton has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2023
- Date Received
- October 26, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enteroscope And Accessories
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To provide visualization and perform various procedures within the small intestine. 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).