Double Balloon Endoscope EN-840T, Over-tube TS-1214C
FDA 510(k) K233321 · FUJIFILM Healthcare Americas Corporation
510(k) numberK233321
Submission
- Device name
- Double Balloon Endoscope EN-840T, Over-tube TS-1214C
- Applicant
- FUJIFILM Healthcare Americas Corporation
Lexington, MA, US - Received
- September 29, 2023
- Decision date
- June 13, 2024
- 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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| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFDA · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 08/20/2015SE |
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| K261713 | Synapse PACS (7.6.0)QIH · Special | 06/18/2026SE |
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000)FDA · Traditional | 09/26/2025SE |
| K243647 | Synapse PACS (7.5)QIH · Traditional | 06/30/2025SE |
| K233629 | APERTO Lucent MRI SystemLNH · Traditional | 05/10/2024SE |
| K233687 | ECHELON Synergy V10.0LNH · Traditional | 05/03/2024SE |
| K233583 | FCT iSTREAM Phase 1JAK · Traditional | 04/26/2024SE |
| K240075 | FUJIFILM Endoscope Model EB-710XTEOQ · Special | 02/07/2024SE |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)ITX · Traditional | 12/13/2023SE |
| K231941 | ARIETTA x10IYN · Traditional | 11/20/2023SE |
| K231574 | Scenaria View 4.2JAK · Traditional | 10/12/2023SE |
Questions and answers
When was Double Balloon Endoscope EN-840T, Over-tube TS-1214C cleared by the FDA?
Double Balloon Endoscope EN-840T, Over-tube TS-1214C (K233321) received a 510(k) decision of Substantially Equivalent on June 13, 2024, 258 days after the submission was received.
What is the product code of K233321?
The FDA product code is FDA – Enteroscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.