FUJIFILM Double Balloon Endoscope EI580BT
FDA 510(k) K183032 · Fujifilm Corporation
510(k) numberK183032
Submission
- Device name
- FUJIFILM Double Balloon Endoscope EI580BT
- Applicant
- Fujifilm Corporation
Ashigara Kami-Gun, JP - Received
- November 1, 2018
- Decision date
- June 24, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDA – Enteroscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
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Questions and answers
When was FUJIFILM Double Balloon Endoscope EI580BT cleared by the FDA?
FUJIFILM Double Balloon Endoscope EI580BT (K183032) received a 510(k) decision of Substantially Equivalent on June 24, 2019, 235 days after the submission was received.
What is the product code of K183032?
The FDA product code is FDA – Enteroscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.