510(k) K112106
K112106 is an FDA 510(k) premarket notification submitted by Smart Medical Systems , Ltd. for the device "NAVIAID ICVI-F,S,B,R DEVICE". The FDA issued a decision of Substantially Equivalent on February 6, 2012. The device falls under product code ODC (Endoscope Channel Accessory), 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
- February 6, 2012
- Date Received
- July 22, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope Channel Accessory
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To give the endoscope channel additional or improved functionality.