FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
NAVIAID(TM) BGC DEVICE
K Number: K111760
·
Decision Aug 9, 2011
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
71
Applicant Total
9
Review Days
48
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Basic Information
- Device Name
- NAVIAID(TM) BGC DEVICE
- K Number
- K111760
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smart Medical Systems , Ltd.
- Date Received
- June 22, 2011
- Decision Date
- August 9, 2011
- Product Code
- ODC
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Smart Medical Systems , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K220158 | G-EYE System | Apr 11, 2022 | Substantially Equivalent |
| K202469 | G-EYE System | Oct 26, 2020 | Substantially Equivalent |
| K192588 | G-EYE System | Apr 15, 2020 | Substantially Equivalent |
| K112106 | NAVIAID ICVI-F,S,B,R DEVICE | Feb 6, 2012 | Substantially Equivalent |
| K110291 | NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE | Jun 17, 2011 | Substantially Equivalent |
| K102616 | NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE | Dec 30, 2010 | Substantially Equivalent |
| K101191 | NAVIAID ICVI DEVICE | Jul 27, 2010 | Substantially Equivalent |
| K060923 | NAVIAID BGE DEVICE, MODEL 21-001 | Aug 15, 2006 | Substantially Equivalent |