FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
K Number: K233321
·
Decision Jun 13, 2024
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
19
Applicant Total
13
Review Days
258
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Basic Information
- Device Name
- Double Balloon Endoscope EN-840T, Over-tube TS-1214C
- K Number
- K233321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM Healthcare Americas Corporation
- Date Received
- September 29, 2023
- Decision Date
- June 13, 2024
- Product Code
- FDA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FDA | Enteroscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | Sep 26, 2025 | Substantially Equivalent |
| K243647 | Synapse PACS (7.5) | Jun 30, 2025 | Substantially Equivalent |
| K233629 | APERTO Lucent MRI System | May 10, 2024 | Substantially Equivalent |
| K233687 | ECHELON Synergy V10.0 | May 3, 2024 | Substantially Equivalent |
| K233583 | FCT iSTREAM Phase 1 | Apr 26, 2024 | Substantially Equivalent |
| K240075 | FUJIFILM Endoscope Model EB-710XT | Feb 7, 2024 | Substantially Equivalent |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | Dec 13, 2023 | Substantially Equivalent |
| K231941 | ARIETTA x10 | Nov 20, 2023 | Substantially Equivalent |
| K231574 | Scenaria View 4.2 | Oct 12, 2023 | Substantially Equivalent |