510(k) K060923
K060923 is an FDA 510(k) premarket notification submitted by Smart Medical Systems , Ltd. for the device "NAVIAID BGE DEVICE, MODEL 21-001". The FDA issued a decision of Substantially Equivalent on August 15, 2006. The device falls under product code FDA (Enteroscope And Accessories), 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
- August 15, 2006
- Date Received
- April 4, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enteroscope And Accessories
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To provide visualization and perform various procedures within the small intestine. 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).