G-EYE System
FDA 510(k) clearance K220158 · decided 2022-04-11
Clearance details
- K-number
- K220158
- Device name
- G-EYE System
- Applicant
- Smart Medical Systems , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-19
- Decision date
- 2022-04-11
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- FDF
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ra'Anana, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.