Naviaid Icvi-F,S,B,R Device
FDA 510(k) K112106 · Smart Medical Systems , Ltd.
510(k) numberK112106
Submission
- Device name
- Naviaid Icvi-F,S,B,R Device
- Applicant
- Smart Medical Systems , Ltd.
Raanana, IL - Received
- July 22, 2011
- Decision date
- February 6, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODC – Endoscope Channel Accessory
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To give the endoscope channel additional or improved functionality.
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| K110291 | Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B DeviceODC · Special | 06/17/2011SE |
| K102616 | Naviaid Balloon Guided Colonoscopy (BGC) DeviceFDF · Traditional | 12/30/2010SE |
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Questions and answers
When was Naviaid Icvi-F,S,B,R Device cleared by the FDA?
Naviaid Icvi-F,S,B,R Device (K112106) received a 510(k) decision of Substantially Equivalent on February 6, 2012, 199 days after the submission was received.
What is the product code of K112106?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.