510(k) K220158
K220158 is an FDA 510(k) premarket notification submitted by Smart Medical Systems , Ltd. for the device "G-EYE System". The FDA issued a decision of Substantially Equivalent on April 11, 2022. The device falls under product code FDF (Colonoscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. Smart Medical Systems , Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2022
- Date Received
- January 19, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colonoscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To examine or perform procedures in the colon or rectum 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).