Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device
FDA 510(k) K110291 · Smart Medical Systems , Ltd.
510(k) numberK110291
Submission
- Device name
- Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device
- Applicant
- Smart Medical Systems , Ltd.
Raanana, IL - Received
- February 1, 2011
- Decision date
- June 17, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device cleared by the FDA?
Naviaid Icvi-F Device, Naviaid Icvi-S Device, Naviaid Icvi-B Device (K110291) received a 510(k) decision of Substantially Equivalent on June 17, 2011, 136 days after the submission was received.
What is the product code of K110291?
The FDA product code is ODC – Endoscope Channel Accessory, a Class II (moderate risk) device regulated under 21 CFR 876.1500.