E-Brik Visualization Assistant
FDA 510(k) clearance K221293 · decided 2022-07-07
Clearance details
- K-number
- K221293
- Device name
- E-Brik Visualization Assistant
- Applicant
- Jdi Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-04
- Decision date
- 2022-07-07
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- OCT
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Highlands Ranch, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.