510(k) K110291
K110291 is an FDA 510(k) premarket notification submitted by Smart Medical Systems , Ltd. for the device "NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE". The FDA issued a decision of Substantially Equivalent on Jun 17, 2011. 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 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 17, 2011
- Date Received
- Feb 1, 2011
- Clearance Type
- Special
- 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
- 510(k)
To give the endoscope channel additional or improved functionality.