ENDOtube
FDA 510(k) clearance K203350 · decided 2021-09-29
Clearance details
- K-number
- K203350
- Device name
- ENDOtube
- Applicant
- Nissha Medical Technologies Sas
- Decision
- Substantially Equivalent
- Date received
- 2020-11-13
- Decision date
- 2021-09-29
- Days to decision
- 320 days
- Clearance type
- Traditional
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Conflans Ste Honorine, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.